Director, Clinical Data Management

About the role:

Reporting to the Chief Development Operations Officer, the Director, Clinical Data Management, is a newly created role to head the Data Management function at IDRx.  The Director, Clinical Data Management will help lead clinical trials and provide oversight for outsourced clinical data management activities by working effectively with CRO partners to develop and standardize data handling plans, data transfer specifications, metrics and data review tools. The position will also develop and maintain study-specific documentation, including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, Data Transfer Specifications, Coding Guidelines, Post Production Database Change Control Documentation, Database Audit and Lock Procedures.  Further, the successful candidate will review and ensure cleanliness of clinical trial data.  

Role and Responsibilities:

• Direct and establish standards for data management CRO outsourcing strategy and deliverables, and the governance of CRO performance.
• Act as Data Management lead for IDRx.
• Lead development and implementation of data collection standards, consistent with industry best practice.
• Review and approve the database design, edit checks, CRF completion guideline, and Data Management Plans drafted by CROs to ensure they are compatible with ensuring CDASH, SDTM and industry standards.
• Represent Data Management at internal cross-functional meetings and external vendor meetings
• Work with vendors to design (e)CRFs and edit checks in the EDC system.
• Perform and document database User Acceptance Testing (UAT) and report UAT.
• Receive, integrate, and reconcile electronic data.
• Perform data review via listings and EDC system, issue and resolve queries.
• Manage queries to ensure data completeness and integrity.
• Review and work with Clinical team on medical coding listings.
• Assist with data listing design for Sponsor data review.
• Perform SAE reconciliation with CRO partner.
• Perform pre-lock and data lock tasks.
• Prepare training materials and user guides for EDC data collection tools.
• Design, generate, and review status metric reports as needed.
• Perform archiving of study databases and related documents.
• Provide input to timelines to ensure timely completion of assigned tasks.
• Provide regular status updates, keeping the team informed of any changes.
• Work with the team to implement technical solutions and resolve issues.
• Additional duties and responsibilities as required.

Requirements:

• Bachelor’s Degree in a scientific or health related field or equivalent and 8+ years of clinical data management experience in biotech or pharma, with experience across EDC platforms, Medidata Rave EDC preferred
• Experience managing global studies utilizing an outsourced CDM model from start-up through close-out
• Experience in a clinical research environment, preferably in biotechnology and focused on Oncology a plus
• Expert knowledge and understanding of regulations and industry-adopted data standards, such as CDISC-SDTM and CDASH
• Solid technical skills across data platforms; programming experience preferred
• Proficient in cross collaboration with other related functions such as Biostatistics, Statistical Programming, Clinical Operations and Pharmacovigilance
• Understanding of FDA and ICH GCP guidelines to ensure appropriate reporting of clinical trial data
• Proficient with data visualization software/tools
• Experience in regulatory GCP inspections/audits preferred
• Ability to manage multiple projects in a fast-paced environment
• Excellent communication and time management skills