- Enanta Pharmaceuticals
- $108,380.00 -167,060.00/year*
2 Barnard Ave
The Associate Director, Clinical Data Management is responsible for planning, implementing and managing Clinical Data Management (CDM) activities across trials and programs, including but not limited to database and technology selections, vendor management, data collection and review, and ensuring quality standards maintained. The Associate Director, Clinical Data Management is also responsible for leading or contributing to company process improvement initiatives. This position reports in to the Head of Clinical Operations.
Primary Duties and Responsibilities:
* Responsible for the oversight of CDM vendors for assigned trials to ensure data quality, integrity and timeliness
* Provides CDM expertise to database set up, CRF design, and data cleaning activities
* Ensures clinical data within EDC is of a quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock
* Coordinates and participates in the review of clinical data, analysis tables/listings/figures and patient profiles for data consistency and accuracy
* Responsible for the selection of suitable vendors for the outsourcing of DM activities, and for building effective DM vendor relationships. This includes being involved in RFP development, contract negotiation and selection of DM and/or technology, as needed.
* Works closely with CROs to prepare and ensure proper execution documents such as CRFs, data management plans, dataset transfer standards, WHODrug and MedDRA coding standards, manual review plans, line listing review plans, and data validation plans
* Ensures clinical databases and external data files are designed in a standard, accurate, complete and consistent format to produce datasets that are conducive to analysis and a possible regulatory submission
* Develops, maintains and implements CDM standards (custom eCRF, CDASH, etc.)
* Ensures data management activities are conducted in accordance with GCP, GCMP, internal SOPs and meet all regulatory requirements
* Leads and/or contributes to department initiatives, and assists in the design and implementation of standardized work processes.
* Interpersonal Skills - Must have the communication and interpersonal skills needed to lead cross functional teams.
* Communication Skills - Strong oral and written communications.
* Productivity/Organizing/Planning - Meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously.
* Strategic Thinking - Capable of proactively identify project challenges and risks, and proposing appropriate and strategic solutions to issues.
* Collaboration & Teamwork - Strong collaboration & teamwork, communications influence, planning & organizing, driving results and problem solving.
Education and Experience Requirements:
* Bachelor's degree in a scientific discipline.
* Minimum of 10+ years of experience in CDM working in a pharmaceutical, biotechnology, Contract Research Organization (CRO) or related environment.
* Experience running Phase I-III clinical trials.
* Working knowledge of GCP, FDA, ICH, CDISC, etc., regulations and guidelines
Associated topics: antibody, clinical, drug, drug development, healthcare, histology, histotechnologist, medical, therapy, virus
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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