Principal Clinical Data Manager - Anywhere, US
This role may be located onsite in our Morrisville, NC or Carlsbad, CA offices or US home based Who We Are
Synteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies. With our mission of "Bringing Clinical Trials to Life," we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in Oncology, Neuro Degenerative Diseases, and Rare and Orphan Diseases, and in pediatric populations. Our mission is to support the innovation and development of better therapies in healthcare.Position Overview
The Principal 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 also presents project-related training, and may provide technical guidance and direction to team members. Experience with budgets, timelines and being a lead within a clinical trial is required for this position.Specific tasks would include:
- 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.
- Bachelor's degree in a related field of study or equivalent combination of education and work experience
- Minimum 4 years experience in clinical research with current trial lead experience
- 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're passionate about bringing clinical trials to life, we encourage you to apply today!
Synteract's policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire. The company will not sponsor applicants to this position for work visas. #LI-CH1