Senior Clinical Data Manager

Precision for Medicine

2d•$133,900 - $200,900

About The Position

The Senior Clinical Data Manager manages all aspects of clinical trial data management for assigned projects, from study start-up through post-database lock. The role follows applicable SOPs/WIs, regulatory directives, and study-specific plans and guidelines, and may oversee or perform database development and testing. As the lead data management contact for assigned clinical projects or programs, this position ensures continuity, responsiveness, timely completion of work, and appropriate backup coverage. It oversees data entry, database quality, data review, documentation, timelines, resourcing, and project deliverables, and coordinates with sponsors, vendors, and cross-functional teams. The role may also contribute to department initiatives, proposals, training, and client-facing activities, and may require occasional travel.

Requirements

Bachelor’s degree and/or a combination of related experience.
At least 8 years of experience as a Clinical Data Manager.
Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.
Ability to handle a variety of clinical research tasks.
Excellent organizational and communication skills.
Professional written and oral English-language skills.
Experience using various clinical database management systems.
Broad knowledge of drug, device, and/or biologic development and effective data management practices.
Strong representational skills and ability to communicate effectively orally and in writing.
Strong leadership and interpersonal skills.
Ability to undertake occasional travel.
Legally authorized to work in the country of employment without employer sponsorship.

Nice To Haves

Experience in a clinical, scientific, or healthcare discipline.
Experience with dictionary medical coding, including MedDRA and WHODrug.
Understanding of CDISC standards, including CDASH, SDTM, and ADaM.
Oncology and/or orphan drug therapeutic experience.

Responsibilities

Serve as the primary Data Management contact and Lead DM for assigned clinical projects or programs, ensuring backup, continuity, responsiveness, and timely task completion.
Provide backup or team-member support to other Lead Data Managers and provide data management oversight for sponsor programs as applicable.
Oversee the project data-entry process, including developing data-entry guidelines, training, data-entry quality, and resourcing; perform data-entry quality control as needed.
Provide input on and manage project timelines, ensure data management deadlines are met with quality, and assess resource needs.
Develop CRF specifications from clinical study protocols and coordinate stakeholder review and feedback.
Assist with clinical database builds as needed; conduct database build UAT, maintain quality-controlled build documentation, and oversee database quality.
Specify requirements for electronic and manual edit checks and other data review types; oversee development of edit-check and manual data-review specifications.
Create, revise, version, and maintain data management documentation, and oversee its completeness in the Trial Master File.
Train clinical research personnel on study-specific CRFs, EDC, and other project-related topics; ensure data management project team members are sufficiently trained.
Review and query clinical trial data according to the Data Management Plan, and perform line-listing review based on sponsor or Lead DM guidance.
Run patient- and study-level status and metric reports.
Perform medical coding of medical terms to ensure medical logic and consistency.
Coordinate SAE/AE reconciliation.
Manage relationships with third-party vendors, including external data and EDC vendors, in support of timelines and data-related deliverables.
Assist with SAS programming and quality control of SAS programs used in the Data Management department as needed.
Identify and troubleshoot operational problems, issues, obstacles, and study barriers using metrics, audit reports, and stakeholder input.
Review and provide feedback on protocols, Statistical Analysis Plans, and Clinical Study Reports when required by the project.
Participate in developing and maintaining SOPs and process documentation related to data management and database management.
Attend strategy meetings, bid-defense preparation meetings, bid defenses, capability presentations, and potential client engagement meetings as needed.
Review RFPs and proposals and provide project estimates as needed.
Provide leadership for cross-functional and organization-wide initiatives where applicable.
Communicate with study sponsors, vendors, and project teams about data, database, and other relevant project issues.
Present software demonstrations or training, department or company training sessions, and project meetings as needed.
Travel occasionally as required.
Perform other duties as assigned.