Associate Director, Clinical Data Management

Proclinical is currently seeking an Associate Director of Clinical Data Management for a biopharmaceutical company located in Piscataway, NJ. Successful candidate will manage end-to-end delivery of data management services for assigned projects/studies, collaborate with CROs and other vendors to ensure high quality deliverables. The Associate Director Data Management will report to the Director, Biostatistics.

Job Responsibilities:

• Serving as primary DM contact to interact with clinical counterparts for project wise data cleaning and issue resolution.
• Reviewing Clinical Data, implementing solutions or escalating as appropriate for Data Consistency, trends/outliers, Coding Appropriateness, Lab Data Reconciliation, and SAE Reconciliation.
• Participating in reviewing requests for proposals and providing budgetary, contractual and scope of work feedback for DM.
• Working with clinical, biostatistics, and CROs to design and develop study documents including Case Report Forms, CRF Completion Instructions, Data Management Plan, Database Specifications, Electronic Edit Checks, and Data Transfer Specifications in CDISC format.
• Managing third party vendors including review of data transfer specifications, managing data deliverables, reconciliation and ensuring quality transfers on time and within budget
• Identifying project risks with input from the cross functional teams and supporting resolving issues. Ensuring that any potential delays are fully mitigated to avoid any delays with full transparency to senior leadership.
• Preparing/overseeing monthly progress reports and ad-hoc reports as required.
• Supporting process improvement and functional trainings at departmental & company level.

Qualifications & Skills:

• BS/BA or higher with relevant professional experience.
• Oncology/Hematology & CAR-T experience is highly desirable.
• 7+ years of pharmaceutical/industry experience in Data Management.
• Demonstrated ability in working with high-performing teams in a matrix and collaborative environment.
• Excellent ability to communicate, specifically on DM topics.
• Sound knowledge of overall drug development process from discovery to registration and post marketing requirements & surveillance.
• Working knowledge of EDC databases is required, preferably Medidata RAVE; experience with JMP a plus.
• Knowledge of FDA/ICH guidelines and industry standard practices regarding data management is required.
• Superior interpersonal skills, & communication skills ensuring full alignment of cross functional teams. Ability to effectively manage conflicts and negotiations while providing impact and influence
• Highly collaborative & effective influencing skills and the ability to operate across multiple geographies.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Junis Citozi at (+1) 929-388-1650 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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