The Director of Global Clinical Data Management (GCDM) is responsible for establishing the Global Clinical Data Management department and providing general direction to and review of the managers across the various functional areas in the GCDM department. The position manages all priorities and workload in the GCDM department. The position manages complex abstract clinical data management projects and is responsible for clinical data management tasks to collect, code, process, review, and validate clinical trial data received in-house and remotely. Activities are performed to ensure complete, accurate, high quality, regulatory compliant data in support of publications and regulatory submissions. Activities are performed according to external regulatory requirements, and internal standard operating procedures (SOPs) and deadlines. The incumbent is responsible for preserving data integrity and adhering to deadlines in order to ensure accurate and on-time regulatory submissions and publications. The position assists in the implementation of the corporate strategic plan in the GCDM department and manages the GCDM budget.
- Assist senior GCDM management on implementing new cross-functional/organizational policies and methodologies.
- Assess corporate goals and business strategies to identify GCDM policies for implementation such as: SOPs, new technologies, clinical data standards, and preferred vendors. Implement and approve new GCDM policies and methodologies.
- Manage GCDM priorities and workload across the functional areas of the GCDM department via its respective managers.
- Approve external GCDM vendor contracts.
- Implement the corporate strategic plan within the department and manage the department budget.
- Develop request for proposals (RFPs) for external vendor cross-functional/organizational contracts. Review external vendor cross-functional/organizational contracts and budget for appropriateness to the project.
- Identify sources of new technologies and/or systems to meet corporate goals and business strategies. Lead implementation team.
- Identify data standards to meet corporate goals and business strategies. Lead implementation team. Activities include:
- Define dictionary versioning process and lead version implementation team.
- Implement and maintain EDC in-licensing.
- Implement and maintain laboratory data standardization, collection, and documentation.
- Serve as GCDM subject matter expert on regulatory audits.
- Provide training and development to GCDM personnel; prepare and conduct performance reviews. Recruits for new staff.
- Perform other activities as required.
- Experience in clinical data management of 10+ years. Experience in managing reports of 7-9 years.
- The position reports to the Senior Director or Executive Director of GCDM.
- Possess management experience; training and development of personnel; and preparation and conducting performance reviews.
- Possess a thorough knowledge of medical terminology; and the clinical data management and the clinical trial process.
- Proficient on regulatory requirements for data management and the regulatory submission process.
- Proficient on SOP development, implementation, and adherence.
- Proficient on serving as a subject matter expert on regulatory audits.
- Proficient on the design and validation of data collection instruments; data standardization, theory, design, collection, and review for implementation of standards and technologies across the Alexion organization.
- Proficient with: (a) CDASH, (b) MedDRA and WHO-DD dictionary coding and versioning, (c) SAS for data review.
- Proficient with an electronic data capture (EDC) system Medidata/RAVE.
- Proficient with the development of CRF/eCRF for clinical trials and its impact into database design/development.
- Proficient on identifying and implementing new data standards, technologies, and systems. Capable of leading cross-functional implementation teams.
- Proficient on developing request for proposals for external vendor contracts, and on evaluating external vendor contract for project procurement. Approve contracts.
- Assess corporate goals and business strategies to identify GCDM policies for implementation.
- Proficient on implementing corporate strategic plan within the department; setting annual budgets and reforecasting appropriately.
- Proficient in working on abstract problems across functional areas of the business, independently taking the appropriate corrective action, and identify and implement improvements. Able to review, interpret and evaluate clinical data.
- Possess effective written and verbal communication skills necessary to interact with personnel at all levels within and external to the company.
- Demonstrate initiative, sound judgment and flexibility; possess effective time management and organizational skills; and be able to work under deadlines and on multiple projects simultaneously.
- Able to effectively coordinate personnel, vendors, teams, and projects.
- Requires a Bachelor’s degree in a scientific discipline or equivalent. A Master’s degree in a related science field is preferred.
Location: Boston, MA, US
Posted Date: 6/5/2020