Associate Director - Clinical Data Management

Proclinical is currently recruiting for an Associate Director of Clinical Data Management with a biotechnology company located in Cambridge, MA. Successful candidate will be responsible for leading the data management processes for the Rare Disease therapeutic area.

Job Responsibilities:

• Lead the data management partnership with CROs for studies in the Rare Disease therapeutic area
• Work effectively with CRO partners to develop and standardize data handling plans, data transfer specifications, metrics and data review tools
• Oversee the activities of CRO DM functional counterparts to ensure adherence to scope of work and service agreements, and to ensure deliverables are met in accordance with study milestones/timelines and with quality
• Perform thorough development testing of the eCRF prior to deployment, inclusive of User Acceptance Test (UAT) Plans, Test Scripts and execute testing applicable
• Implement, track and review key performance indicators on data management activity across the Rare Disease program
• Collaborate with clinical study teams and vendors to ensure project deliverables are met, including data acquisition, quality data review and reporting in compliance with GCP, SOPs and regulatory requirements
• Participate in the Data Standards Committee and act as the liaison between the study team members Rare Diseases to standardize data collection and reporting

Skills and Requirements:

• Master's or bachelor's degree in computer science or a science-based subject with at least 10 years of clinical data management experience in industry, with experience across indications and EDC platforms (or Doctorate with at least 5 years of experience in industry); or a bachelor's degree outside of computer science or a science-based subject with a minimum of 12 years of clinical data management experience in industry, with experience across indications and EDC platforms
• At least 3 years of management experience in a clinical research environment, most of which should be in industry and preferably across therapeutic areas
• Vendor management and oversight experience
• Strong technical skills across data platforms
• Experienced in designing clinical trials utilizing CDASH and SDTM standard terminology
• Cross collaboration proficiency with other departmental functions such as Biostatistics, Statistical Programming, and Pharmacovigilance
• Thorough command of FDA and ICH GCP guidelines to ensure the appropriate reporting of clinical trial data
• Experience in regulatory GCP inspections/audits
• Outstanding verbal and written communication skills, in addition to excellent organizational skills
• Ability to manage multiple projects in a fast-paced environment
• Creative, capable problem-solver

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 Felix Hook at (+1) 646-367-2617 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.

Proclinical Staffing is an equal opportunity employer.

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