Job Description
The Clinical Data Manager actively participates in all aspects of the data management process from the development of project documentation, system set-up, User Acceptance Testing (UAT), and routine data review through database lock of clinical trials. The CDM has a broad, fundamental knowledge of the data management process and can plan, manage, and coordinate activities for assigned tasks with minimal guidance. This person may have project level oversight as a study Lead Data Manager. The core duties and responsibilities of the CDM are delineated below
Manages data management duties to meet study timelines.
Review and may distribute/coordinate data management metrics, listings, and reports.
Performs scheduled and ad hoc data listing review and generates/resolves queries in EDC
Performs external data reconciliation against EDC.
Performs Serious AE reconciliation according to SOPs and guidelines, as applicable.
Provides DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables.
Generates and/or reviews/approves study documents (e.g., Data Management Plans, Case Report Forms, DB build specifications, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, laboratory data handling plan, study protocols).
Reviews protocols for appropriate data capture including electronic Case Report Form (eCRF) design and external data vendors’ systems.
Reviews and provide feedback to the clinical team on other study documents e.g.,Clinical Monitoring plans and vendor specifications.
Maintains study DM related documents/files for inspection readiness.
May oversee data management CRO/service providers including manages and monitors the progress of data management activities with CROs and/or other service providers on assigned studies; build effective relationships with CRO/service provider counterparts.
May assist with the training of new employees and/or contractors (e.g., clinical data associates and/or junior clinical data managers working on the studies).
May participate in CRO/vendor selection process for outsourced activities.
May participate in the development, review and implementation of departmental SOPs, templates, and processes.
Contributes to a professional working environment through exemplifying Core Values
Required Skills, Experience and Education:
Bachelor’s degree
At least three (3) years of CDM of Data Management experience in the pharmaceutical, biotechnology, or CRO industry; depth and exposure to DM related tasks considered in lieu of minimum requirement.
Requires solid knowledge of clinical data management principles, clinical trials process and regulatory requirements.
Good working knowledge of ICH, FDA, and GCP regulations and guidelines.
Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint).
Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug.
Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment.
Ability to handle multiple project tasks and prioritize effectively.
Well organized and detail oriented.
Proven ability to work both independently and in a team setting.
Preferred Skills:
Bachelor's degree in health sciences, Life Sciences, or health-related field.
CRO/service provider experience desired.
Prior oncology/solid tumor experience.
Knowledge of industry standards (CDISC, SDTM, CDASH).
Job Tags
Remote job, Contract work, For contractors,