Job Description / Summary
The Manager, Clinical Data Management is a full-time exempt position reporting to the Director, Clinical Data Management.
PLEASE NOTE: Candidates must have a valid Green Card or U.S. citizenship. No visa sponsorship is available now or in the future.
Must Have
- 12+ years of hands-on data management experience.
- 6-7 years of managerial experience, managing a team of at least 5 people.
- 4+ years of experience in the CRO environment.
- Excellent oral and written communication skills.
- Ability to work in the PST time zone (flexible).
- Willingness to travel 2-3 times a year when necessary.
Responsibilities
- Provide data management expertise to project teams, clients, and CROs, including study startup documents, data cleaning, DCF/query tracking, database QC, and SAE/AE reconciliation.
- Oversee development of specifications for eCRFs/CRF, edit checks, electronic data handling, manual review, and User Acceptance Testing.
- Conduct cross-functional data reviews, identify issues, and track resolutions.
- Innovate and implement new technologies for process improvements.
- Ensure adherence to quality control procedures.
- Write and update SOPs/training guidelines.
- Facilitate internal study team, client, and CRO meetings.
- Review study data quality, provide metrics, and report out-of-scope activities.
- Manage timelines and resources to meet deadlines.
- Identify and recommend solutions for process inefficiencies.
- Assist in preparing proposals and budgets for new and ongoing projects.
- Direct and manage team members, including training, resource assignment, and performance reviews.
Education and Experience Requirements
- 12 years of hands-on data management experience.
- 6-7 years of managerial experience, managing a team of 5+ people.
- B.S./B.A. in a science or technical discipline with 8 years of data management experience, or MS degree with 6 years of data management experience; minimum 4 years in the Pharmaceutical/Biotechnology industry or CRO environment.
- Proficiency in SQL or SAS is desirable but not required.
- Experience with various data collection and EDC systems.
Knowledge & Skills Requirements
- Excellent oral and written communication skills.
- Ability to work collaboratively in a multi-disciplinary environment.
- Good knowledge of FDA, EMA, ICH guidelines, and GCPs, especially related to data handling and processing.
Salary and Benefits
- Market rate compensation as base salary with all the benefits.
Originally posted on Himalayas