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Home Based Anywhere Associate Director/Director, Clinical Data Management (Science & Biotech)
Long Island City, NY 11101
Recruited by: Sheryl Horowitz | Recruiter | F-O-R-T-U-N-E Personnel Consultants, Inc. See all my Jobs

  • Hiring Company: F-O-R-T-U-N-E Personnel Consultants, Inc.
  • Industry: Science & Biotech
  • Compensation: Salary
  • Expires: Mar 13, 2021
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Job Description

JOB SUMMARY
The Associate Director/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, staff management, study proposals/budgets and ensuring quality standards are maintained.
The Associate Director/Director, Clinical Data Management is also responsible for leading or contributing to company process improvement initiatives. This role will provide comprehensive Clinical Data Management expertise to meet all Clinical Data Management sponsor needs.
REQUIRED EDUCATION, KNOWLEDGE, SKILLS AND ABILITIES
• The position requires at least a bachelor’s degree in clinical, biological, or mathematical sciences with minimum of 12 years of experience in clinical data management of clinical trials; at least 4 years team management experiences.
• At least 5 years of working experience in Medidata RAVE and Medrio platforms. Certified RAVE or Medrio builder is a plus.
• Comprehensive understanding of clinical drug development processes
• In-depth knowledge of all Clinical Data Management processes from study start-up to study close-out
• Comprehensive experience with at least one clinical data management system (CDMS) including direct experience and/or understanding with database design, set-up and user acceptance testing; edit check development and/or programming and validation; management of data entry and queries; and study change control
• Understanding of the contributions of other functions critical to the execution of clinical trials and their interaction with Clinical Data Management
• Experience with vendor management
• Highly effective leadership skills
• Capable of proactively identifying project challenges and risks and proposing appropriates and strategic solutions
• Excellent communication/interaction skills including presentation skills. Strong collaboration and teamwork skills
• Able to lead CDM team through complex issues/problems
• Able to perform long range planning
• Able to work in face-paced environment with challenging priorities and timelines
• Highly organized and detail-oriented
• Strong technical and problem-solving skills.
• Experience with generating and managing Clinical Data Management proposals and budgets.
• Experience working with GCP, FDA, ICH, CDISC etc. regulations and guidelines
RESPONSIBILITIES
• Serve as the expert in Clinical Data Management (CDM) to provide oversight and advise to the clinical project team as it relates to CDM activities and deliverables
• Provide leadership and guidance to all Clinical Data Management personnel
• Manage and resolve escalated issues related to Clinical Data Management
• Develop presentations and represent Clinical Data Management in client and study meetings such as bid defense, study qualification, budget meetings etc.
• Oversee all Clinical Data Management activities to include but not limited to study start up, data cleaning, archiving and timelines
• Management of proposals, budgets, invoices and outsourcing
• Manage and develop Clinical Data Management staff and resources. Engage in recruiting for the department and administer performance reviews/promotions/disciplinary actions/terminations. Address all staffing issues
• Evaluate and identify efficiencies and process improvements including leading process improvement projects and technological upgrades to improve CDM workflow/deliverables
• Lead the Clinical Data Management team in meeting study deliverables and timelines
• Assign clinical studies to Clinical Data Management team as needed
• Assure compliance with SOP’s and Work Instructions
• Develop and maintain Clinical Data Management morale, engagement and professional development
• Develop and maintain good communications and strong relationships with project team members as well as Sponsor, CRO, vendor, and project team members
• Oversee CDM training, training record management and quality control processes. (e.g. Standard Operating Procedures/Work Instructions, study-specific training, GCP, new hires etc.). Ensure CDM team maintains compliance with GCP, FDA, ICH, CDISC etc. regulations and guidelines
• Maintain professionalism
• Adhere to corporate processes and policies
• Other duties as assigned