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Data Management Lead (Director / Sr Director)

Boston, MA 02109

Posted: 01/25/2023 Employment Type: Direct Hire/Perm Job Category: Data Sciences Job Number: 538955 Is job remote?: No Country: United States

Job Description

 
Position Summary

Planet Pharma's biotech client is seeking an experienced and motivated Director or Sr. Director, Data Management Lead to join their rapidly growing organization. Reporting to the VP, Head of Biometrics, this critical position will lead the data management function to support clinical development programs. The position represents Biometrics as the subject matter expert in Clinical Data Management and provides strategic planning and tactical direction for Clinical Data Management activities across all projects in all phases of development. This person will conduct vendor selection and provide oversight to data management consultants and outsourced vendors, ensure the DM team is in compliance with SOPs and processes, and proactively recommend process improvement to increase efficiency of the data management function as well as ensuring it is in regulatory compliance.

 


Responsibilities
  • Leads Data Management function to support all projects and studies.
  • Performs vendor qualifications regarding Data Management functions and manage vendors regarding data management issues and activities to ensure on time deliverables within budget.
  • Works with the existing Data Management FSP teams in supporting ongoing studies.
  • Represents Biometrics as the subject matter expert in Clinical Data Management (CDM) by providing strategic planning and tactical direction for Clinical Data Management activities across all projects in all phases of development.
  • Provides oversight of and guidelines to CROs to ensure timely delivery and regulatory compliance of outsourced activities; may oversee CROs’ data management function inspections and audits.
  • Directs, with executive oversight, Clinical Data Management activities, including CRF/eCRF design, database development, validation programming, discrepancy management, and database releases.
  • Identifies and evaluates fundamental issues, providing strategy and direction for major functional areas.
  • Sets visions for Clinical Data Management, operations, infrastructure, and technology.
  • Promotes and leads standardization, automation, innovation, implementation of policies, standards and process improvement, and technology enhancement in Clinical Data Management and beyond to increase drug development efficiency.
  • Ensures Data Management Plans (DMPs) are consistent and in regulatory compliance across studies and programs to meet the growing needs of the company portfolio (DMP includes Case Report Form (CRF), CRF completion guidelines, SAS annotated CRFs, data handling plan, data entry review guidelines, data edit check specifications, data transfer specifications, database audit plan, and database release plan).
  • Adheres to departmental and regulatory agency procedures and standards.

 

Required Qualifications
 
  • MS or equivalent; preferably in the scientific/healthcare discipline.
  • At least 12 years of Clinical Data Management experience in the pharmaceutical or biotechnology industry.
  • Proven leadership and management skills to lead Data Management group, and the ability to hire and develop team members.
  • A proactive and independent thinker in problem solving; ability to anticipate data management related problems with the ability to recommend creative technical solutions to avoid potential issues.
  • Experience in managing multiple CROs, ePRO, and EDC vendors.
  • Advanced knowledge of CDM processes, systems, and technology advancements.
  • Full understanding of ICH, GCP and other global regulatory guidance related to data.
  • Advanced working knowledge of data management principles, including knowledge of CDISC Standards.
  • CNS drug development experience is a plus.
  • Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
  • Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company.
  • Attention to detail and quality are critical to success.
  • Highly accountable for the results and outcomes of their responsibilities and understands the impact of their efforts, results, and attitudes on others.
  • Uses teamwork to work cooperatively toward the most effective solutions, championing the best ideas of team members, and assisting where help is needed yet is capable of highly independent work when efficiency is required.
  • Results-oriented individual who is highly motivated, decisive, flexible in thought, and has the creativity to excel in and contribute to a rapidly growing company.
  • Forward thinking mindset with the ability to manage multiple projects, and identify and resolve issues.
  • Broad experience in an emerging, publicly traded company environment is a plus.
     
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