Alexion Pharmaceuticals Associate Director, Clinical Data Management in Boston, Massachusetts
This position can be based from any of the following Alexion locations; San Francisco, CA, Boston, MA, New Haven, CT, or Blue Bell, PA or be remote/virtual, based anywhere in the United states and may require up to 20% travel.
The Associate Director of Global Clinical Data Management (GCDM) is responsible for directly and independently managing a subgroup of clinical data management aligned around a specific therapeutic are(s) with its associated subordinates, budgets, and schedules. The position manages all priorities and workload in the GCDM department. The position manages highly complex 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. The position requires the ability to manage projects and its associated teams, vendors, budgets, and timelines. The position requires activities to develop, modify, and execute company policies. 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 position is responsible for preserving data integrity and adhering to deadlines in order to ensure accurate and on-time regulatory submissions and publications.
Job Duties & Responsibilities
Manage GCDM personnel, priorities, and workload on the preparation, validation, processing, reviewing, querying, dictionary coding, and maintenance of clinical data on individual clinical trials and regulatory submissions.
Approve request for proposals (RFPs) for external GCDM vendor contracts. Develops and evaluates external GCDM vendor contracts and budget for project procurement.
Manage CROs, external vendors, and clinical trial project teams.
Implement new approved technologies and/or systems.
Serve as subject matter expert to focus expertise and problem solving strategies on one or more of the following areas below for use across all clinical trials. Lead implementation team(s) appropriately and develop, implement, and version data standards.
MedDRA and WHO-DD Coding – Implement centralized dictionary coding and dictionary versioning.
Electronic Data Capture, Medidata/RAVE – Implement screen/system development; expertise on underlying data structure and data storage; manage technical system problems and take corrective action; support ad-hoc report development.
CDASH – Implement and perform versioning; develop global standard CDASH case report form library and code lists; implement in EDC.
- Laboratory data standardization and collection – Define global laboratory standards library and reports; perform laboratory data review, standardization, identify data discrepancies and corresponding resolutions
Lead the clinical project team to develop CRF/eCRF according to CDASH for clinical trials.
Validate GCDM department to ensure audit readiness. Serve as GCDM subject matter expert on regulatory audits.
Develop and finalize global clinical data management SOPs. Develop, modify, and execute cross-functional company policies.
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 7+ years.
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.
Experience in developing SOPs
Experience having served as a subject matter expert on regulatory audits.
Proficient on the design and validation of data collection instruments; the data collection and data review process; data standardization; laboratory data theory, design, and collection.
Proficient with 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 implementing new data standards, technologies, and systems. Capable of leading implementation teams.
Proficient on developing request for proposals for external vendor contracts, and on evaluating external vendor contract for project procurement.
Experience in solving extremely complex and increasingly difficult problems, 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.
Competence with MS Office programs, particularly Word, Excel and PowerPoint
Self-motivated, reliable team member
Ability to communicate effectively with senior management as well as with peers
Excellent written and verbal communication skills
Good planning skills
Ability to solve problems of challenging nature
Adherence to timelines
Proficient with: (a) CDASH, (b) MedDRA and WHO-DD dictionary coding and versioning, (c) SAS for data review.
Obtained Certified Clinical Data Manager (CCDM) from the Society of Clinical Data Management
A Master’s degree in a related science field is preferred.