Overview
The Sr. CDM is responsible for managing the data management activities for multiple clinical trials. Will work closely with internal team members and vendors to ensure that assigned clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH / GCP / regulatory guidelines, company goals and expectations, and budget.
New Haven CT location preferred, 3 days / week; Remote will be considered with the expectation of travel to CT office at least once / month.
Responsibilities
- Oversee CRO data management counterparts for assigned clinical trials and ensure that the data management objectives are met in accordance with current SOPs, WPDs and timelines and budget.
- Initiate CRF development for new clinical trials and protocol amendments; collaborate with internal team and responsible vendor on CRF development, database design and edit specifications.
Ensure established clinical data standards are followed.
- Review CRO Data Management Plans, Data Review Plans and other applicable data management documents for completeness and accuracy.
- Create internal Data Review Plans for review / approval by study team members and coordinate the internal data review process;
oversee and track clean patient status.
- Create Data Transfer Plans for external data vendors for review / approval by study team members; perform external data reconciliations as applicable
- Review protocols, Statistical Analysis Plans and statistical outputs taking CRF / Database into consideration.
- Assist in the creation / review of clinical data standards, DM WPDs and Instruction Documents.
Qualifications
Education / Experience :
- Excellent oral and written communications
- Good interpersonal skills and ability to deal with people at all levels with sensitivity and tact
- Excellent organizational, multitasking, and priority management skills
- Strong computer skills including knowledge of Microsoft Excel, Word, and Outlook
- Ability to work within established timelines, in a fast-paced environment, managing multiple clinical trials, non-study projects, and ad-hoc assignments
- Bachelor's degree in science or similar area with experience
- 5+ years prior experience in clinical data management
- Preferred experience with oncology, dermatology, allergy
- Experience with clinical data standards
- In-depth knowledge of data management, including interpretation and implementation of FDA regulations / lCH guidelines, and GCP is required
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