The Manager, Clinical Data Management will be responsible for lead data management responsibilities for 2-3 concurrent clinical trials, as well as oversight of several others. Utilizing the Medidata RAVE electronic data capture and management system. The selected candidate will manage trials in various stages, from planning, to set-up, conduct, closeout, and archiving. The candidate will assist with maintaining a high level of data quality by creating and adhering to standard CRFs and data structures and corresponding standard edit checks and review listings. The selected candidate will assist in the design and implementation of clinical data management processes with vendors, ensuring completeness, correctness, and consistency according to the Sarepta standards. This role will collaborate with the Clinical Operations team members, and with other functions as applicable.
Primary Responsibilities Include:
Clinical Data Management (CDM)
- Project level coordination of assigned program, including set-up and attendance in meetings, Clinical Data Review, creation/coordination of timelines for various deliverables and other CDM activities as needed.
- Oversight of DM and external data vendors
- Work collaboratively with Programmers, Biostatisticians, Clinical Operations, Medical Monitors, and Regulatory staff to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting
- Ensure completeness, correctness and consistency of clinical data and data structure across projects
- Participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting CDM
- Communication and escalation of project level issues including processes, timelines, resourcing, performance, etc.
- Assist with support of regulatory submission activities for assigned projects
- Assist with response to questions and findings from Clinical Quality Assurance and other audits at the study / vendor level
- Communicate with functional peers regarding project status and issues and ensure project team goals are met
- Provide guidance and training to CROs, vendors, investigators, and study coordinators on study requirements as applicable
- Excellent verbal and written communication skills and interpersonal skills are required
- Working knowledge and experience with FDA regulations and familiarity with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide coding dictionaries such as MedDRA
- Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines
- Assist in preparation of clinical documentation for IND updates as well as NDA and other regulatory submissions, as appropriate
- Assist as needed with reports and clinical documents such as clinical protocols, informed consent, Investigator Brochure, yearly updates to the regulatory authorities and status updates
- Collaborate with Clinical Operations to ensure the Clinical Trial Master File (TMF) is set up and maintained appropriately throughout the trial
Education and Skills Requirements:
- Minimum - a BS degree in a Biomedical Science or equivalent
- Minimum 6 years of relevant experience along with clinical background/experience in Clinical Data Management in a CRO or bio/pharmaceutical setting
- Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials required
- Proficient written and verbal communication skills
- Ability to collaborate effectively with the study team, cross-functional team members and external partners using collaborative negotiation skills
- Management experience of CROs and Vendors
- Strong computer skills including knowledge of Microsoft Office Suite
- Position may require some travel.