We seek an experienced Manager, Clinical Data Management, to join our InClin team.
Benefits:
- - Remote Work
- - Medical, Dental, Vision, and Life Insurance
- - Flexible Spending Account (FSA) / Health Savings Account (HSA)
- - 401(k) with 3% match
- - Paid Time Off (PTO) and Bereavement Leave
- - And more...
Manager, Clinical Data Management, is a full-time exempt position reporting to the Director, Clinical Data Management. 6 years of experience leading and managing a team is required.
In this role, you will oversee data management activities across clinical studies, ensuring compliance with regulatory standards and industry best practices. You will lead a team, manage timelines, and collaborate with internal teams, clients, and Clinical Research Organizations (CROs) to ensure high-quality data collection, processing, and reporting.
RESPONSIBILITIES
The main responsibilities of this role include but are not limited to the following:
- Provide data management expertise and support to internal project teams, clients, and Clinical Research Organizations (CROs) including the following:
- Study startup documents, data cleaning, DCF/query tracking, database QC, compilation and maintenance of data management binders and/or files, and SAE/AE reconciliation
- Plan, perform, and oversee the development of specifications for eCRFs/CRF, edit checks, electronic data handling, manual review, and execution of User Acceptance Testing
- Conduct and orchestrate scheduled cross-functional data review, identification of issues, and track through resolution
- Participating in innovation and implementation of new technologies resulting in data management process improvements
- Ensure adherence to quality control procedures for data management activities
- Write appropriate Standard Operating Procedures (SOPs)/training guidelines and oversee revisions /updates to current SOPs/training guidelines for data management activities
- Facilitate and oversight of internal study team, client, and CRO meetings
- Actively review and provide feedback on study data quality including providing data management metrics, review project statement of work, and identify and report to Director any requested out-of-scope activities
- Manage and monitor timelines and assuring resources are available to meet timelines
- Identify inconsistencies and inefficiencies in data management processes and recommend solutions
- Assist in the preparation of proposals and budgets for new projects as well as manage budgets for ongoing projects
- Direct and manage team members in daily activities including providing training, resource assignment, adherence to timelines and conducting annual performance review.
EDUCATION AND EXPERIENCE REQUIREMENTS
KNOWLEDGE & SKILLS REQUIREMENTS
- Excellent oral and written communication skills
- Ability to work in a collaborative and multi-disciplinary environment
- Good knowledge of Food and Drug Administration (FDA), Europe Medicines Association (EMA), International Conference on Harmonisation (ICH) guidelines, and Good Clinical Practices (GCPs) including regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing
Why Work at InClin?
At InClin, we are more than just a clinical research organization. We are a team of passionate professionals committed to driving innovation in clinical development. When you join InClin, you become part of a dynamic and supportive environment where your expertise is valued, and your contributions make a real impact.
Salary Range: $110,000 - $149,990/annual
