Clinical Data Manager (FSP)
Hey you! Yes you reading this ad! Are you ready for the greatest step in your career? Well if you are still reading this it means that on some level you must be interested in a change. Perhaps this is the positive change you need.
Proclinical is currently seeking Clinical Data Managers as part of our FSP model where you will be working full time as a Proclinical employee and be on assignment to one of our premier global clients where you will gain knowledge, not only from your Proclinical cohorts, but from the client team you will be running. How is that for career growth, knowledge from two organizations all wrapped in one position.
This role is a full-time, fully benefited position and part of our growing and highly sought after FSP Model. As a Proclinical employee you will be eligible for Medical, Dental, 401K and eligible for paid time off, including holiday, vacation, sick/personal time and annual performance reviews.
Clinical Data Manager (DM) is responsible for the coordination and delivery of Data Management contracted services on assigned projects. This includes meeting internal and external sponsor requirements according to time, quality, scope and budget parameters. The DM is the primary point of contact for Data Management on a project, for internal project team members, sponsors, and external data vendors. The DM presents project-related training, and may provide technical guidance and direction to team members.
- Serves as the primary Data Management interface for internal project team members, sponsor representatives, third party CROs, and external data vendors.
- Ensures the timely initiation, conduct, and completion of Data Management activities on clinical trials.
- Leads a sub-team of Data Management staff members assigned to a project.
- Tracks Data Management timelines for assigned projects and ensures that all applicable Data Management team members are aware and on target for deliverables.
- Authors the Data Management Plan (DMP), outlining all data management responsibilities.
- Authors the Data Transfer Agreement (DTA) with third party external data vendors
- Oversees UAT of clinical data systems (EDC, eCOA, IWRS) to be implemented on a project.
- Conducts project-specific training throughout the course of the project, as needed.
- Attends and presents at client bid defense meetings.
- Attends and presents at project meetings as required.
- Oversees the completion of a comprehensive data review of clinical data.
- Ensures medical coding is performed in a timely manner
- Ensures DM documentation is audit-ready and filed appropriately at all times.
- Coordinates all activities in preparation for database lock, including Data Review Meeting.
- Oversees the production of status or progress reports, listings, and other output as required during the course of the project
- Monitors budget and scope of work for contracted DM services throughout the duration of the project, identifying out of scope or budget activities, and collaborating with the project manager when out of scope documentation and costs are needed.
Skills and Requirements:
- Bachelor's degree in a related field of study or equivalent combination of education and work experience
- Minimum 2 years experience in clinical research
- Demonstrated experience in a lead role
- Knowledge of ICH/GCP standards, 21 CFR Part 11.
- EDC experience; knowledge and experience with Rave desired
If you are having difficulty in applying or if you have any questions, please contact Russ Bland at (+1) 267-435-8555 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.