The Associate Clinical Data Coordinator serves as Signant Health’s champion to the world’s largest pharmaceutical and biotech companies in providing clean and accurate data for clinical trials. All changes to the eCOA database are managed in line with the company’s quality management system and supported by the appropriate study documentation to guarantee compliance with regulatory authorities and/or the company’s Sponsors. An ideal candidate will demonstrate a strong analytical and rigorous thought process. This position will interact daily with the Project Delivery resources of the company. Additionally, an Associate Clinical Data Coordinator is charged with preparing trial archives. The accuracy and timeliness of these contracted services are critical. As an Associate Clinical Data Coordinator you will be based part of a team and working out of our You will interact with a wider team split across the US and Romania.
Key Accountabilities/Decision Making & Influence
- Implement and verify Data Clarification Forms (DCF) submitted through the TrialManager®
- Under the direction of the Manager, Data Reconciliation, effectively manage DCF workload determined by TrialManager®
- Implement assigned project timelines and prioritization of tasks.
- Assist in the resolution and response to issues and questions from client study team, physicians and site staff
- Conduct site and sponsor archival processes during study decommissioning
- Act as CDM resource person for internal teams
- Update of Maintenance Guides
- Ongoing knowledge of study activities, protocol updates, data requirements and relationships to facilitate DCF verification and implementation
Diversity and Inclusion Competencies
- Dedication and commitment to promote diversity, multiculturalism and inclusion in all work activities
- Ability to collaborate in diverse teams to foster productive outcomes.
- Emphasis on removing bias in decisions related to promoting, hiring, leading, training and coaching team members.
- Advocate for diverse perspectives and model inclusive behavior.
- Influence others to promote, embrace and progress an inclusive environment.
Knowledge, Skills & Attributes
- Bachelor’s degree or relevant experience
- Ability to operate within cross-cultural, multi-disciplinary teams and therapeutic areas
- Team oriented
- Good working knowledge of Excel
- Good written and oral communication skills
- Deadline oriented
- Detail oriented
- “Can Do” Attitude