Careers

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10015 Biostatistician Manager, Biopharmaceuticals

Job Description –

Perform trial statistician responsibilities including reviewing CRFs, review of protocols/amendments, conducting exploratory data analyses.
Serve as a statistical and project manager for biostatistics deliverables across assigned programs
Plan and track study level activities within programs, including resources; ensure CRO timelines are met
Perform trial statistician responsibilities including reviewing CRFs, review of protocols/amendments, conducting exploratory data analyses, and performing just-in-time analyses
Apply innovative statistical approaches to study design, analysis and data exploration methodologies, including Bayesian adaptive methods to dose finding
Help to maintain data standards, within and across programs.
Ensure that the clinical studies meet scientific, regulatory, and quality requirements
Plan and manage submission activities, like SCS, SCE, briefing books.
Serve as a general clinical development and statistical resource; participate in non-clinical project activities
Develops statistical analysis programs to merge complex data structures from multiple databases, create analysis data set (ADS) and generate tables, listings, and figures (TLF) for reports.
Participate in development of database clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic, and data validations. Ensures data specifications align with statistical analysis requirements and goals.
Contributes to the development of processes, procedures, and standards associated with analysis of clinical studies, data management, and reporting for regulatory submissions.

Qualifications Requirements –

MS Biostatistics and 5+ years in biopharmaceutical industry as a biostatistician
Proficiency in statistical programming (SAS, R) and query of relational database systems (SQL).
Certifications in SAS, R, EAST programming a plus.
Experience with clinical study closeout and clinical study designs
Prior Experience with regulatory submissions
Experience with extraction of data and reporting within Clinical Data Management systems
Strong knowledge of statistical theory, experimental design and clinical trial methodologies, linear and nonlinear modeling, categorical and non-parametric methods, sample size calculations.
Familiar with FDA guidelines and other regulatory requirements is a plus. • Experience with analysis of complex data from multiple sources.
Ability to work independently and in project teams.

Benefits –

401(k)
Disability insurance
Flexible schedule
Health insurance
Life insurance
Paid time off

10026 Clinical Data Management Sr. Manager

Job Description –

Functions will include but are not limited to oversight of outsourced clinical data management activities, development of clinical trial data management documents, and shaping further development of the data management function.
Establishes metrics for data management, oversees vendor performance relative to expectations, and devises operational efficiencies where needed
Provides strategic, tactical and operational input to cross functional team
Oversees performance of vendors for outsourced functions
Responsible for delivering actionable clinical data from assigned clinical program(s)
Translates development goals into relevant, tangible and measurable objectives for the clinical development team and drives optimal delivery
Engages key stakeholders to ensure expectations of clinical development operations are being met or exceeded

Qualifications Requirements –

Bachelor’s degree required, Master’s Degree or greater preferred
10+ years of experience in data management in either as a Sponsor or CRO organization
Experience overseeing CROs and/or other vendors on a clinical trial
Experience in development and implementation of CDM standards and procedures

Benefits –

401(k)
Disability insurance
Health insurance
Life insurance
Paid time off
Bonus pay

10037 Statistical Programmer

Job Description –

Perform data analysis using primarily the SAS programming language for the summary and interpretation of medical/clinical data.
Ability to independently write, test, and validate SAS programs, and review resulting output and data
Ensure accurate and timely completion of the statistical programming activities for assigned projects, such as exploratory and formal data analyses for final study reports, abstracts, posters, manuscripts, and ad-hoc projects, including verification and documentation of results.
Participate in review of analysis plans and development of programming requirements as needed.
Exercise independent judgment in selecting and adapting, as necessary, methods appropriate for the specific objective.
Independently verifies other programmer’s results.
Supports project biostatistician, requiring minimal guidance.
Oversee and project manage the activities of lower level personnel and contractors on assigned projects, as needed, but primary role is an individual contributor.
Proactively identifies and resolves or escalates issues that could impact the quality or timely completion of a deliverable.
Ability to program defensively, check results, and consistently produce accurate output.
Ability to work on multiple projects and prioritize tasks to meet project needs.

Qualifications Requirements –

- 5+ years of relevant experience in academia or pharmaceutical or medical device industry.
- Bachelor’s in Computational or Biological Sciences.
- Professional working knowledge in multiple therapeutic areas, oncology, and genomics.
- Working knowledge of R.
- Professional working knowledge in an FDA regulated environment.

Authorization to work in the United States without sponsorship.

20014 Clinical Research Data, Director

Job Description –

Prepares and submits regulatory documentation both internally and externally
Ensures adherence to data privacy and security standards
Manages implementation of clinical validation protocols
Monitors data acquisition and quality
Develops presentation materials for a business audience
Uses methodologies such as scrum to help organize and prioritize tasks
Prepares and submits regulatory documentation both internally and externally
Collaborates with marketing teams to recruit members into new initiatives
Performs ROI analyses
Independently manages complex projects

Qualifications Requirements –

Requires a Master’s in clinical, biological, social, or statistical sciences or related field.
4 – 5 years’ experience in a scientific role; or any equivalent combination of education and experience.
digital health experience preferred
Requires knowledge of best practices for clinical trials and good clinical practices;
maintaining a principled approach to scientific initiatives that prioritizes patients’ best interests.
Experience working with institutional review boards; a focus on flexibility and solving problems; and

20025 Clinical Development Scientist

Job Description –

Coordinate review of clinical trial data, including gathering, analyzing, reviewing, and interpreting data; Provide preliminary assessments and recommendations.
Develop clinical strategy, create clinical development plans, write clinical protocols and report results.
Collaborate with biostatisticians, and outside consultants to provide clinical science inputs into clinical evidence plans.
Write abstracts, manuscripts, and clinical study reports.
Support assessment of issues relating to protocol conduct and subject safety.
Evaluate research proposals for scientific, medical, business, scientific, and operational feasibility.
Facilitate communication of relevant scientific, clinical, or other findings to both internal and external stakeholders.

Qualifications Requirements –

PhD, PharmD, or MD in a life science or health science related field
6+ years of experience in medical device/IVD, biotech, pharmaceutical or biochemistry
A comprehensive understanding of the medical device development process and testing standards.
Working knowledge of the FDA submission process, including IDE and PMA
Basic understanding of biostatistical principles for study design and data analysis.
Authorization to work in the United States without sponsorship.
Demonstrated ability to perform the Essential Duties of the position independently

20035 Medical Director

Job Description –

Perform medical and related safety/efficacy data reviews with minimal senior clinicians.
Responsible for analytical support of clinical trial data, including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations.
Analyze information to assess issues relating to protocol conduct and/or individual subject safety.
Author protocols and contributes to authoring of clinical study reports, IBs, other clinical and regulatory documents.
Prepare and communicate a clear overview of trial results.
Partner with cross-functional program and study-level teams with minimal oversight by senior clinicians
Oversee the design and conduct of clinical studies, including operational feasibility, data management deliverables, preparation of meeting materials, communication plans and study close-out activities.
Interact with internal and external stakeholders
Act as recognized clinical expert for assigned programs
Present at investigator meetings and scientific conferences.

Qualifications Requirements –

Minimum educational requirement: MD or DO degree, Board Certified in Family Practice,
4 years of experience at a pharmaceutical, CRO or biotechnology company as a clinical scientist or related role – title will be commensurate on experience
Experience in oncology or immunotherapy clinical trials and Early drug development preferred.
Requires knowledge of best practices for clinical trials and good clinical practices
Experience working with institutional review boards
Demonstrated ability to evaluate, interpret and present complex scientific data.
Ability to handle multiple projects at a time.

20046 Chief Medical Officer

Job Description –

Provides clinical leadership in the development, organization and governance of a clinically integrated network of physicians or Population Health Services Organization
Provides change management expertise in health systems, provider organizations, and physician practices
Responsible for leading the improvement of clinical, quality, and financial outcomes for the operating partnerships
Participates in the alignment of physician incentives, quality measures, and value-based contracts
Maintains strong relationships with Provider Medical Directors and clinical leaders at partnering organizations
Support the advisory services team in content development and supporting the delivery of V2Vs.
Directs and monitors medical management activities and quality management programs as needed to maintain compliance with CMS and other accrediting bodies

Qualifications Requirements –

MD. or D.O. degree, plus Board Certification.
Minimum of five years successful clinical practice experience.
Minimum of three years of health system, health plan or capitated provider experience with quality documentation and coding
Strong background in administrative clinical leadership•
Prior operational consulting experience a plus.
Solid understanding and experience with population health management strategies
Knowledge of continuous quality improvement theory and practice.
Excellent communication and problem-solving skills.

20057 Medical Monitor

Job Description –

Provide medical expertise, advice, and guidance to members of the clinical development project teams as and when required.
Provide on-call medical support for urgent medical inquiries.
Provide medical support for routine medical inquiries for internal and external study teams and sites.
Review and approve all versions of the patient information leaflet and informed consent form templates.
Participate in review and approval of study protocols, with focus on study design, scheduled assessments, and protection of subject safety.
Participate in the draft, review and ownership of study-specific medical monitoring plans (MMP).
Review study statistical analysis plans.
Provide appropriate clinical training for internal and external study team members and site personnel when required before and during conduct of studies.
Provide medical advice and ensure that all medical questions raised during study conduct are answered appropriately and in a timely manner.
Review serious adverse events (SAEs) that occur during studies and assist Global Drug Safety in identifying any emergent safety concerns that may be related to study conduct.
Review safety information including adverse events and clinical laboratory data during study conduct.
Review the outputs of safety signal detection analysis and recommend appropriate remedial
action as necessary to ensure the protection of subject safety.

Qualifications Requirements –

US Board-certified M.D. strongly preferred
2-4 years of experience in a business context or scientific role
Requires knowledge of best practices for clinical trials and good clinical practices;
experience working with institutional review boards;

20068 Sr. Scientist - Director of Clinical Pharmacology

Job Description –

Leading clinical pharmacology studies of the highest complexity
Developing and implementing new clinical pharmacology tools and technologies to drive smarter drug development for programs.
Providing strategic leadership and demonstrating accountability for the clinical pharmacology programs supporting Phase 1-4 clinical development for development compounds in your therapeutic area
Developing and maintaining collaborative working relationship with colleagues within and outside the department
Authoring/reviewing/approving clinical protocols, analysis plans, study reports and regulatory submissions
Developing high quality clinical pharmacology plans and content for global regulatory submissions, including INDs, IBs, NDAs, MAAs and pediatric plans
Evaluating departmental and broader organizational SOPs as fit for purpose.
Ensuring adherence to agreed timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs

Qualifications Requirements –

- At least 7+ years’ experience and a, PhD, PharmD or MD degree with emphasis in clinical pharmacology or a related scientific discipline
- In-depth knowledge of pharmacokinetic and other analysis software programs
- Thorough knowledge of current and emerging scientific standards regulatory requirements for assigned territories
- Confidence and ability to present to and influence senior leaders
- Ability to critically analyze problems and provide creative solutions

Confidence and discipline to work autonomously

30012 Clinical Research Associate

Job Description –

Responsibilities may include, but are not limited to:
Manages clinical monitoring activities and the overall site management ensuring compliance with Good Clinical Practices (GCP) and applicable regulations and tracking of site performance metrics
Obtains, reviews, and approves all required essential documents necessary for study/site initiation and drug shipment.
Assists with set-up of central labs and study vendors as required, including liaising with Project/Program Manager and CRO to ensure site training and timely initiation
Tracks lab samples, work with CRO and vendors to resolve discrepancies
May perform accompanied site visits with CRO CRAs to ensure correct study procedures according to SOPs
Reviews monitoring trip reports and track resolution of all action items
Supports in the development and design of CRFs, including participating in the EDC and IWRS specification process and UAT
Performs in-house review of clinical data listings for completeness and accuracy and escalate issues to the Project/Program Manager, as needed
Supports and may lead the development and review of clinical study plans, presentations, or study-related documents
Prepares and presents project progress reports
Organizes and manages internal team meetings, investigator meetings, and other trial specific meetings, as requested
Perform routine review of the eTMF for the active studies and follow up with CRO on the findings through resolution

Qualifications Requirements –

Bachelor’s degree, preferably in a biological science
Relevant clinical trial experience in the pharmaceutical or health care industry or equivalent
Microsoft Office proficiency required.
Understanding of ICH GCP guidelines.
Understanding of clinical trial processes life cycle
Ability to establish priorities, sense of urgency and collaborate with the study team, cross functional.
Proven problem solving and decision-making skills

30024 Clinical Trial Associate/Administrator

Job Description –

Communicate with internal team members and CROs regarding trial start-up, maintenance, and close-out activities.
Provide support for Investigator Meeting planning, including organizing meeting materials
Assists in the oversight of vendor activities along with the CRO.
Develop Trial Master File (TMF) plan and manage through transfer of documents to the Sponsor
Provides guidance with development of the clinical trial binders for study sites.
Manage and track study-specific payments and invoices.
Oversee CRO tracking systems and tools to support the conduct of a clinical trial
Provides support to CSM on startup activities
Collaboratively work with CRO to ensure CTMS has current updated information.
Manage tracking and delivery of clinical/non-clinical supplies.
Provide support to both internal and external departmental members when necessary.

Qualifications Requirements –

- Bachelor’s degree or equivalent.
- 5+ years in clinical research, or health related industry is required
- Highly effective verbal and written communication skills
- Experience with effective vendor management preferred.
- Demonstrates an aptitude for strategic thinking skills; manages
- Excellent planning and organizational skills
- Practices the ability to influence and negotiate to achieve team goals.
- Demonstrates creativity and innovation to support projects and initiatives.

Self-motivated, achievement-driven and exhibits ability to work with minimal guidance

30035 Clinical Trial Specialist

Job Description –

Organizes and delivers reports and metrics
Collates data for assessments such as feasibility and site selection.
Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings
Compiles study manuals including but not limited to: study reference binders and manuals and maintains versioning of study reference materials
Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures

Qualifications Requirements –

- 4+ Years of Clinical Trial Experience
- Reviewing Informed Consent Form Experience
- Start up through closure

2+ years of managing Trial Master File

Demonstrated analytical skills.

Familiarity with clinical trial protocols and reports desirable.

Ability to work on results and protocols from multiple therapeutic areas.

Strong communication skills.

30045 Clinical Study Manager

Job Description –

Develop study-related documents, including Case Report Forms, study protocols, study manuals, and coordinate distribution to investigational sites and review committees.
Support the study team by resolving protocol-specific questions, such as patient eligibility and protocol deviations.
Coordinate activities associated with study start-up.
Develop and maintain project timelines, budgets, and prepare regular operations reports.
Manage distribution, collection, and tracking of regulatory documentation to assure audit readiness at the sites.
Monitor progress of studies, communicating updates to study team, identifying trends and issues, and implementing corrective actions when necessary.

Qualifications Requirements –

Bachelor’s degree or higher in a scientific or healthcare discipline preferred.
3-5 years of progressive experience in clinical research or clinical operations within the biotech, pharmaceutical sector or CRO industry.
Experience developing trial plans including site monitoring, pharmacy and lab manuals, risk mitigation strategies, trial budgets and site selection/feasibility as required.
Proficient written and verbal communication skills.
Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials required.
Management experience of CROs, Vendors and Consultants preferred.
Therapeutic or medical knowledge preferred
Regulatory authority inspection experience a plus

Benefits –

Medical / Dental / Vision / Wellness Programs
Paid Time Off / Company Paid Holidays
401K with Company match
Life and Disability Insurance
Tuition Reimbursement
Employee Referral Bonus

30056 Project Manager

Job Description –

Act as primary liaison with clients.
Lead and direct cross-functional team leaders and third parties/vendors with minimum supervision and support.
Manage project contractual deliverables, including progress via metrics and adherence to contractual agreement time, quality/scope, and cost deliverables).
Participation and attendance in bid defense process.
Maintain detailed understanding of each functional service area and lead multifaceted functional teams effectively with little supervision or support.
Develop in depth analysis and projections of project timelines and financials for senior and customer management.

Qualifications Requirements –

Minimum of 5 years’ experience in clinical research, including a minimum of 2 years full-service project management experience or an equivalent combination of education and experience
Undergraduate degree in clinical, science, or health-related field, preferred
Licensed healthcare professional (i.e., registered nurse), preferred
Minimum of 1 year of drug development experience, preferred
Travel of up to 25% is required for this position.
Applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

30067 Director of Operations

Job Description –

Monitor activities at clinical study sites to ensure compliance with Good Clinical Practices, IDE, SOPs, and study protocols.
Collect data/observations and obtain product development feedback.
Interact directly with clinical sites, including clinical investigators and other health care professionals involved in the clinical study
Develops operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management.
In collaboration with functional management, coaches, mentors, supports, and provides study specific direction to team members.
Act as a liaison directly between our company and clinical sites.
Ensure clinical studies are conducted in a timely manner and within site budgets.
Assist in preparation of reports for submission to regulatory agencies.
In collaboration with the Medical Director, assist in building effective and efficient high performing operations teams.

Qualifications Requirements –

Degree in life sciences, health sciences or equivalent degree/experience.
8 years’ experience implementing and monitoring clinical studies preferably involving diagnostics tests.
Proficient in FDA and cFDA regulations, as EU regulations and GDPR for clinical studies and medical devices, including GCPs.
Strong project management, documentation, and organizational skills
Must be detail- and accuracy-oriented, precision is essential
Experience of project managing operational aspects of a clinical study including development of timelines, budgets and resource plans.
Experience of working as part of a study or functional teams.

30079 Clinical Trial Liaison

Job Description –

Develop and maintain successful relationships with study-center healthcare providers, including clinical trial investigators, study nurses/coordinators, data coordinators, and other study professionals to support patient recruitment activities
Work closely with sites and site personnel to develop study and/or site patient recruitment and retention tactics and strategies appropriate to the individual study needs
Work with CRO personnel (CRAs, CTMs, PMs) to ensure proper study conduct, review trends and help develop mitigations for implementation
Responsible for oversight of monitoring activities performed by CRO to ensure compliance with monitoring plan for study and appropriate issue escalation
Contribute to development and review of clinical study documents
Assist with identification of potential clinical investigators

Qualifications Requirements –

5 years of previous experience as, monitoring/clinical research associate, clinical study coordinator
Applied understanding of any Good Clinical Practices
Additional experience should include demonstrated computer skills
Ability to handle and prioritize multiple therapeutic areas and projects simultaneously
Experience working independently in a regional area with remote or minimal supervision
Competencies and essential skills in the following: cross functional relationships, decision making, execution/results/process improvement, customer satisfaction
Prior experience guiding and mentoring clinical study staff, and patient recruitment and strategic patient recruitment planning experience is highly desirable

Benefits –

401(k) with company match and Annual Retirement Contribution Plan
Tuition reimbursement Company match of charitable contributions
Health & Wellness programs including onsite flu shots and health screenings
Generous time off for vacation and the option to purchase additional vacation days

30089 Medical writer Regulatory

Job Description –

Reporting to a Medical Writing Team Lead, the Principal Medical Writer guides medical writing activities for key clinical and regulatory documents and regulatory submissions.
Working across therapeutic areas to provide support as needed
Responsible for preparation of key clinical and regulatory documents and documents supporting major regulatory submissions and responses to regulatory authorities.
Provide functional and cross-functional guidance on a wide range of issues related to document preparation, including international regulatory guidance.
Lead the writing strategy providing expertise including organization, content, timelines, and resource requirements.
Manage deliverables and preparation of documents for submission to FDA or other regulatory agencies, ensuring consistency of content within therapeutic areas.
Represent Medical Writing on cross-functional teams and task.

Qualifications Requirements –

6 years of experience writing clinical/regulatory documents for a pharmaceutical or biotechnology company is required.
Experience as lead writer for key documents included in major US and/or international regulatory submissions required.
Experience managing writing activities for a major US and international regulatory submission.
Understanding of clinical development, including the phases, processes, and techniques used within a clinical development from protocol design through regulatory submission.
Understanding of FDA/international regulations, ICH guidelines, and US/international regulatory processes.
Well-developed oral and written communication skills.

40015 Health Economics Professional

Job Description –

Full responsibilities in health economics and health outcomes project conception and implementation
Prepares technical reports and papers on study plans, progress and results of research activities
Designs research protocols
Evaluates and recommends statistical methods for data analysis and monitors and interprets results of analysis
Evaluates, recommends and implements procedures for data management and quality control
Designs and oversees the implementations of research protocols and/or technical specifications
Prepares technical reports and papers on study plans, progress, and results of research activities
Reviews literature evaluate impacts of health care reform policies, and issues position statements to policy changes
Formulates research objectives
Plans, organizes and schedules activities to meet strategic research objectives
Identifies research funding sources and opportunities
Establishes and maintains an active network of professional contacts

Qualifications Requirements –

Preferred Doctoral degree or Pharmacy Degree
5+ years of related experience and/or training
Experience analyzing large medical and pharmacy claims databases
Strong understanding of the health services research environment
Knowledge and experience in marketing and project management

50023 Medical Science Liaison

Job Description –

Full responsibilities in health economics and health outcomes project conception and implementation
Prepares technical reports and papers on study plans, progress and results of research activities
Designs research protocols
Evaluates and recommends statistical methods for data analysis and monitors and interprets results of analysis
Evaluates, recommends and implements procedures for data management and quality control
Designs and oversees the implementations of research protocols and/or technical specifications
Prepares technical reports and papers on study plans, progress, and results of research activities
Reviews literature evaluate impacts of health care reform policies, and issues position statements to policy changes
Formulates research objectives
Plans, organizes and schedules activities to meet strategic research objectives
Identifies research funding sources and opportunities
Establishes and maintains an active network of professional contacts

Qualifications Requirements –

Preferred Doctoral degree or Pharmacy Degree
5+ years of related experience and/or training
Experience analyzing large medical and pharmacy claims databases
Strong understanding of the health services research environment
Knowledge and experience in marketing and project management

60015 Patient Safety Scientist/Physician

Job Description-

To execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports
To assure medical validity of ICSRs and provide input to the activities of Medical Safety Review Team (MSRT)
Execute the medical review of ICSRs to ensure quality reports. Produce medically accurate ICSRs reports
Act as MSRT product lead and/or therapeutic area lead as assigned
Execute appropriate case follow up per SOPs
Contribute in Safety Assessment Team (SAT)
Conduct reportability assessment for medical device complaints/malfunctions and review for potential product problems.
Performs other duties related to the position as necessary as defined in SOPs or as requested by his/her supervisor
Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility

Qualifications Requirements –

Medical Qualification MD or international equivalent
Clinical and/or Drug Safety experience
5 + years of relevant work experience

Benefits –

Medical / Dental / Vision / Wellness Programs
Paid Time Off / Company Paid Holidays
401K with Company match
Life and Disability Insurance

70034 Regulatory Affairs Manager

Job Description –

Serves as a subject matter expert on various regulations and coordinates regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed.
Ability to maintain regular and predictable attendance. Assists in the preparation of regulatory submissions to achieve departmental and organizational objectives.
Requires the ability to provide solutions based on their own knowledge and industry experience base. Detailed activities include:
Providing active and ongoing regulatory guidance to project teams
Document regulatory strategies for product submissions.
Facilitate FDA pre-submission meetings and prepare U.S. regulatory submissions
Perform regulatory assessment of new and changed products.
Conduct trainings and/or communicate appropriate materials, as needed, in order to enhance team’s knowledge of working in a regulated environment.
Participate in business meetings with potential new external partners
Acts independently to determine and coordinate methods and procedures on new assignments.
Ensure all activities comply with U.S. Food and Drug Administration regulations, international regulations and other regulatory requirements, company policies, operating procedures, processes, and task assignments.
Participates in inspections/audits by the notified body or other international regulatory bodies by producing requested documents.

Qualifications Requirements –

majors in Science or Engineering are preferred.
5+ years of experience working in a medical device regulated environment/industry are required.
RAC Certification preferred
Good understanding on IVD product life cycle and performance characteristics.
Excellent communication skills and attention to detail
Post market experience preferred

80031 Associate Director, Clinical Quality

Job Description –

Independently plans, conducts and concisely reports results of audits of clinical investigator sites, service providers and internal processes.
Assist in implementing and executing compliance programs
Periodically assesses the adequacy of CQA Standard Operating Procedures, with the ability to improve and develop key processes when tasked.
Works collaboratively with both internal and external clients as well as with regulatory agencies to anticipate and resolve quality issues as well as maintain GCP compliance.
Supports any regulatory inspections, should they occur.
Supports other GxP functions as required.
Travel may be required

Qualifications Requirements –

Master’s degree & 4+ years of directly related experience
4+ years of Good Pharmacovigilance Practice experience, with the ability and direct experience to self-start and help establish a pharmacovigilance program.
Strong experience leading external site and vendor audits, as well as internal process audits.
Strong knowledge of US FDA regulations and guidance documents associated with GCP.
Experience in the facilitation of regulatory inspections.
Ability to anticipate and resolve problems effectively.
Able to multi task, well organized, detail oriented, and able to prioritize and manage multiple projects at one time.

Careers

10015 Biostatistician Manager, Biopharmaceuticals

10026 Clinical Data Management Sr. Manager

10037 Statistical Programmer

20014 Clinical Research Data, Director

20025 Clinical Development Scientist

20035 Medical Director

20046 Chief Medical Officer

20057 Medical Monitor

20068 Sr. Scientist - Director of Clinical Pharmacology

30012 Clinical Research Associate

30024 Clinical Trial Associate/Administrator

30035 Clinical Trial Specialist

30045 Clinical Study Manager

30056 Project Manager

30067 Director of Operations

30079 Clinical Trial Liaison

30089 Medical writer Regulatory

40015 Health Economics Professional

50023 Medical Science Liaison

60015 Patient Safety Scientist/Physician

70034 Regulatory Affairs Manager

80031 Associate Director, Clinical Quality

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