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15 days old

Clinical Data Manager

Kelly Services
Lawrence, NJ 08648
Responsibilities will include, but are not limited to:


Project Management and Leadership

Provides clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projects

Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects

Responsible for end to end clinical data management activities and serves as a primary point of contact for internal and external study team members

Provides strong quality and project oversight over third party vendor responsible for data management deliverables

Takes a leadership role to gather content and integration requirements for EDC and close collaboration with partners supporting other data collection systems (eCOA, External Data, Safety Gateway). Enforces data standard conventions and quality expectations for clinical data per defined processes

Authors, reviews/revises DM related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization

Chairs Data Quality Review meetings with cross functional study team members to ensure on-going review of trial data currency , quality and completeness

Represents DM on cross-functional project teams & submission Teams

Lead or support the Health Authority inspections and audits

Provides coaching and quality oversight of junior Data Management Leads


FSP/CRO/Vendor Oversight

May act as core member of the study team and provides FSP/CRO/Vendor oversight for end-to-end Data Management activities, manages data currency throughout the trial, and overall monitoring DM deliverables according to the Service Level Agreement (SLA)


Continuous improvement initiatives

Provides the relevant support and input to continuous improvement activities within clinical data management

Provides support for CAPA implementation as required


Degree Requirements Bachelors Degree required with an advanced degree preferred


Experience Requirements At least 5 years of relevant industry experience. Project management certification (e.g. PMP) is desirable.


Key Competency Requirements

Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors

Sound knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management

Strong knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills and well versed in industry trends and emerging technologies supporting data collection

Strong project management; Exhibits expertise in metrics analysis and reporting methodologies

Excellent oral and written communication skills

Communicate effectively with senior management and cross-functional teams

Knowledge of submission requirements, [e.g. New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA)]


Travel Required Yes, 5-10% Industry Conferences, Investigator Meetings, Regulatory Inspections (as needed)




**Why Kelly** **** **?**



Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-01-11 Expires: 2021-02-25

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Clinical Data Manager

Kelly Services
Lawrence, NJ 08648

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