Director, Data Management

SK Life Science • Paramus, NJ

6h

About The Position

Overview The Director of Data Management will be responsible for collecting and managing clinical trial data clearly, accurately and securely. The individual will work collaboratively with vendor to assure that Data Management functions are performed in compliance with regulations and according to study protocol. The individual will also responsible for managing, coaching and mentoring of junior level clinical data managers. Responsibilities Responsible for data management documentation, including, but not limited to data management plan(DMP), CRF, eCRF design, edit check specifications, data issue logs, and data review plans and ensures all documents follow study design and regulatory requirements Maintain Data Management outsourcing metrics and key performance indicators to aid the selection of CRO partners / Vendors and the ongoing management of partnerships. Participate in vendor qualifications and audits. Oversees the planning, execution, and maintenance of major projects Review clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations. Review queries and tracking status Be accountable for EDC database (DB) specification process, EDC user guides and ensure clinical data within EDC is in good quality, Review User Acceptance Testing (UAT) summary report Responsible data transfers between vendors and/or Sponsor Responsible for reconciliation of external data and IRT (Interactive Response Technology) Monitors data clean-up process performed by CROs from study start-up through data archiving. Working closely with statistics and statistical programming team to solve data issues founded and support data review Coordinate the archiving of study databases and related documents Collaborate with IT and implementation team (s) to address changes to Clinical database systems. Ensure data system compliance by following the established guidelines of national and international regulatory authorities Responsible for managing, coaching and mentoring of junior level clinical data managers Supervision Exercised: Supervise, coach and mentor junior level clinical data managers

Requirements

• MS degree in science related field.
• Minimum of 10 years Pharmaceutical industry data management experience.
• Working knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology
• Working knowledge of Clinical database applications such as EDC and CTMS
• Applicable knowledge working with other clinical databases such as SAS.
• Experience with working on Phase I-IV study trials within the pharmaceutical industry
• Working knowledge of industry standards, such as the ICH guidelines, CDISC data structures, and FDA guidelines
• Excellent organizational skills, time management, and ability to meet established deadlines
• Excellent verbal and written skills, good organizational, interpersonal, and team skills
• Excellent multi-tasking skills
• Ability to work effectively across a matrix organization.
• Ability to work independently and collaboratively and ability to manage, coach and mentor junior level clinical data managers

Responsibilities

• Responsible for data management documentation, including, but not limited to data management plan(DMP), CRF, eCRF design, edit check specifications, data issue logs, and data review plans and ensures all documents follow study design and regulatory requirements
• Maintain Data Management outsourcing metrics and key performance indicators to aid the selection of CRO partners / Vendors and the ongoing management of partnerships.
• Participate in vendor qualifications and audits.
• Oversees the planning, execution, and maintenance of major projects
• Review clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations.
• Review queries and tracking status
• Be accountable for EDC database (DB) specification process, EDC user guides and ensure clinical data within EDC is in good quality, Review User Acceptance Testing (UAT) summary report
• Responsible data transfers between vendors and/or Sponsor
• Responsible for reconciliation of external data and IRT (Interactive Response Technology)
• Monitors data clean-up process performed by CROs from study start-up through data archiving.
• Working closely with statistics and statistical programming team to solve data issues founded and support data review
• Coordinate the archiving of study databases and related documents
• Collaborate with IT and implementation team (s) to address changes to Clinical database systems.
• Ensure data system compliance by following the established guidelines of national and international regulatory authorities
• Responsible for managing, coaching and mentoring of junior level clinical data managers

What This Job Offers

• Job Type: Full-time
• Career Level: Director