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Associate Director, Clinical Data Management (CDM) Operations

  • Salary:
  • Job type:
    Direct Hire
  • Posted:
    2 months ago
  • Category:
  • Deadline:
    September 30, 2023
  • Job Level:

Associate Director, Clinical Data Management (CDM) Operations

Direct Hire/Hybrid

Salary $185,000 – $198,000

South San Francisco, CA


Option 1 Staffing is currently recruiting for an Associate Director, Clinical Data Management (CDM) of Operations.  The Associate Director, Clinical Data Management (CDM) Operations, is a leadership role responsible for overseeing all study-team facing activities within a specific therapeutic area. This position provides operational and technical guidance for CDM in clinical trials, acts as an advisor to other functions, and participates in project management and strategic teams.

Major Duties and Responsibilities:
– Serve as a subject matter expert for CDM Operations, ensuring the planning, coordination, and timely delivery of high-quality clinical trial data for decision-making, regulatory approval, and market acceptance.
– Contribute to the development of processes, infrastructure, and staffing for the CDM function, including electronic data capture, external data integration, and end-to-end data standards.
– Collaborate with internal stakeholders, such as regulatory affairs and R&D, to assess and meet data management needs, representing CDM in project team activities and meetings.
– Manage relationships with CROs, clinical sites, and laboratories to ensure efficient and timely collection of clinical data.
– Oversee the identification, evaluation, and validation of CDM documents and databases required for reporting and regulatory submissions.
– Conduct thorough testing of eCRFs prior to deployment and generate data listings for study metrics reporting.
– Contribute to the selection and management of CDM vendors, ensuring quality and timely deployment of clinical trial data collection.
– Ensure compliance with protocols, SOPs, and clinical objectives, developing SOPs as needed.
Education Requirements:
– Bachelor’s degree required; Master’s degree preferred.
– Minimum of 8 years of experience in a fast-paced pharmaceutical/biotechnology position, managing multiple trials simultaneously.
– 5+ years of supervisory and management experience.
– Strong understanding of clinical data management processes, CDASH and SDTM data formats, and clinical study objectives and methodologies.
– Excellent knowledge of the clinical trial database life cycle, including CRF design, database development and testing, data quality review, and database close and lock procedures.
– Expertise in industry-leading eCRF tools, such as IxRS and eCOA/ePRO.
– Familiarity with database and dictionary structures, such as MedDRA.
Experience Requirements:
– Commitment to quality programs and data-driven program evaluation.
– Excellent interpersonal, written, and verbal communication skills, with the ability to communicate technical information to non-technical audiences.
– Proficiency in Spotfire or other programming tools preferred.
– Experience with EDC vendors and processes, preferably Medidata Rave.
– Extensive knowledge of CDISC standards, specifically SDTM datasets/SDTM mapping.
– Experience in strategizing and creating data management tools to enhance work product.
– Thorough understanding of the drug development process and regulatory guidelines governing clinical trials.
Option 1 Staffing is an award winning, statewide, recognized leader in staffing and recruiting, specializing in placing the highest caliber of Non-Clinical Healthcare, Information Technology, Supply Chain, Administrative/Office and Accounting/Finance professionals in contract and direct-hire opportunities. We work with top and emerging companies in the Technology and Healthcare industry.

We Offer:
  • Excellent opportunity to work for a outstanding, large and growing company!
  • Renown Healthcare Organization – Huge career growth potential!
  • Awesome Benefits!
  • Excellent salary!
  • Medical Insurance
  • 401K

For immediate consideration, please apply!

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