Primary point of contact providing guidance and oversight of Clinical Data Management activities supporting study start up, in stream production data review, and database closure across Client Projects. Manage budgets, timelines, and resources while ensuring compliance with GCP regulations, policy and Client Company policy.
- Manage all operational aspects of clinical trials in compliance with GCP regulations, PRAHS policy and Client Company policy.
- Review and manage project budgets, timelines and resources across Client programs and studies.
- Ensure timeliness of deliverables for each phase of the study from study start-up through production and close-out activities.
- Interact with various Data Management and other functional area colleagues, including, but not limited to: Biostatistics and Programming, Clinical, Project Management, Safety, Medical Coding, site personnel.
- Ensure Clinical Data Management staff maintains all relevant documentation associated with each assigned Protocol.
- Indentify and work collaboratively and cross-functionally to implement process improvement measures within data management on both departmental and project level.
- Coordinate with Clinical Data Management Staff, Client, and Study Team to identify issues/trends for discussion.
- Participate in study/project team meetings as primary facilitator of timelines, providing updates on study status to the cross functional team.
- Escalate any potential or actual issues to supervisor, project team, and/or Client Company in a timely manner, and follow issues through to resolution.
- Provide written project status reports to Client Company and/or PRAHS Data Management supervisor and verbally present as necessary at Client Company meetings.
- Delegate or assist with delegating daily tasks for all protocol(s) to Lead Clinical Data Managers, Clinical Data Managers, and/or Data Entry staff.
- Contribute to the development and/or revision of Clinical Data Management SOPs and related documentation.
- Assist in establishing metrics for project progress, performance, and cost. Assist in evaluating project performance to these standards.
- Monitor performance goals and objectives to ensure quality in the processing of data generated from clinical trials.
- Serve as primary point of contact for all Client Company project timeline related communication.
- Assist supervisor as needed with resource planning/forecasting
- Monitor and work to maintain/improve Client Company satisfaction by ensuring high quality service, communication, and management of clinical data.
- Escalate potential/actual issues regarding, IT connectivity, Sponsor relations, staffing needs that could potentially impact timelines and deliverables to PRAHS management
- Maintain awareness of team members’ PTO requests, ensuring all Sponsor deliverables will be maintained.
- Contribute to Annual Employee Performance Evaluations as needed, upon request of management.
- Establish appropriate project tracking using computer assisted programs and ensure timely entry of project information.
- Evaluate and manage project budget against project milestones to ensure project profitability. Take corrective measures where necessary to keep project in line with budget and profit expectations.
- Conduct internal and external project team meetings as needed.
- Assist supervisor with interview and selection process of new staff.
- Support documentation of initial and ongoing staff training as required by both PRAHS and the Client Company.
- Work closely with the CDM Proposals, Clinical Operations, Medical Affairs, Strategic Alliances, Strategic Development, Strategic Operations and Information Service Departments to perform appropriate client, indication and therapeutic area research to support the proposal development and required study change orders.
- Bachelor of Science or Bachelor of the Arts, OR at least 7 years Clinical Data Management experience
- Minimum 7 years experience in Clinical Data Management
- Significant experience leading multiple protocol(s) simultaneously required
- Minimum 2 years supervisory experience preferred.
- Demonstrate knowledge of Clinical Data Management processes.
- Knowledge of clinical / medical terminology.
- Excellent verbal and written communications skills and ability to interact with personnel at all levels cross-functionally.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.