Manager/Lead, Clinical Data Management

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Manager/Lead, Clinical Data Management

04 Sep 2024
Massachusetts, Cambridge, 02138 Cambridge USA
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Manager/Lead, Clinical Data Management

Vacancy expired!

Job#: 1277097

Job Description:

Lead/Manager, Clinical Data Management 1277097
Job Scope & Purpose:
Our Cambridge client is seeking a Manager, Clinical Data Management. This position will be responsible for managing and supporting clinical trials in various stages, from planning, to start-up, conduct, closeout, and archiving. In addition, you will lead and support the design and implementation of clinical data management processes with vendors, ensuring completeness, correctness, and consistency. Apply today if you are ready to grow your career! This role can be remote.
Primary Job Responsibilities:
  • Provide vendor management oversight ensuring data management activities for clinical trials within assigned research program(s) are completed in a timely and accurate manner.
  • Study level coordination and hands on CDM tasks, including clinical data review.
  • Oversees development of, edit check specifications, CRF Completion Guidelines or Data Entry Guidelines, Data Management Plan, Data Review Guidelines, SAE Reconciliation Plan, with input from cross-functional study team
  • Ensure completeness, correctness and consistency of clinical data and data structure across projects.
  • Lead and support the development, review and implementation of processes, policies, SOPs and associated documents affecting CDM.
  • Participate in the review of clinical data, analysis tables, listings, figures, and patient profiles for data consistency and accuracy
  • Communication and escalation of study level issues including processes, timelines, resourcing, performance, etc.
  • Works independently and cross functionally, communicating with functional peers regarding project status and issues and ensure project team goals are met.
  • Working knowledge and experience with FDA regulations and experience with web-based Electronic Data Capture (EDC) and clinical data management systems.
  • Ensure accurate tracking and reporting of study metrics and timelines
  • Develops timelines and reviews budgets, contracts and change orders to ensure departmental and corporate clinical trial data management objectives are met.
  • Supports project teams on achieving delivery of quality data, on-time and on-budget.
  • Participates in vendor and technology (e.g., EDC) evaluation, qualification and selection. Supports RFP development and contract negotiation, as needed.

Primary Job Requirements:
  • Minimum 6 years of relevant experience along with clinical background/experience in Clinical Data Management in a CRO or biotech/pharmaceutical setting; and a minimum of 3 year of experience leading clinical studies.
  • Extensive Clinical Data Management experience including study start up, initiation, close out etc.
  • Excellent verbal and written communication skills and interpersonal skills
  • Experience using Electronic Data Capture tools
  • Ability to collaborate effectively with the study team, cross-functional team members and external partners
  • Demonstrate leadership skills and the ability to lead teams and motivate team members, as needed.
  • In-depth Knowledge of FDA regulations, Google Cloud Platform, GCDMP and ICH guidelines required.
  • Self-sufficient and able to work with minimal oversight. Able to prioritize workload and meet deadlines
  • Strong computer skills including knowledge of Microsoft Office Suite

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

PROVEN SCIENTIFIC PLACEMENT™

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.



Code: ClinOps

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or

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