Associate Director, Clinical Data Management
Bachelor’s degree or equivalent in health-related field preferred
7+ years of experience in clinical data management in the pharmaceutical/biotechnology
Manages all aspects of the clinical trial data management process from study start up to database lock for Electronic Data Capture (EDC) trials managed in house and those contracted to Clinical Research Organizations (CROs)
• Lead Data Management (DM) contact and contributor for assigned clinical studies. Serves as an active member of Study Teams.
• Works with other functions to manage timelines and ensure that clinical data management deadlines are met.
• Liaises with third-party vendors such as CROs and central laboratories in support of timelines and data-related deliverables.
• Responsible for working with database builders to develop EDC databases, edit checks and reports.
• Defines database and edit check specifications to support the protocol and analyses.
• Develops UAT requirements for new study databases and revisions; tests according to UAT Plan.
• Create and maintain data management documentation.
• Regularly review and query clinical trial data as indicated in the Data Validation Specifications.
• Help design listings in support of clinical and medical review of data.
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders.
• Train other personnel on CRF and EDC, as needed.
• Coordinate with Pharmcovigilance on adverse event reconciliation.
• Review and provide feedback on draft protocols, Statistical Analysis Plans, CSRs and other documents as required. Participates in the development and maintenance of Standard Operating Procedures (SOPs) and Work Instructions related to data management activities.
• Helps develop Data Management standards.
• May train and/or supervise the daily responsibilities of more junior staff as assigned.
• Other duties as assigned
• Proficiency in the area of clinical data collection, cleaning and analysis
• Excellent experience working in cross-functional team-oriented environments
• Demonstrates strong project management skills
• Understanding of ICH and regulatory environment as it pertains to data management
• Working knowledge of at least one EDC system
• Understands and routinely considers how data management decisions impact other functional areas and deliverables
• Experience with SDTM/C-DASH is a plus
• Industry covering Phase I – Phase III studies
• Electronic data capture expertise required
• Working knowledge of SDTM and C-DASH principles desirable
Will directly supervise staff as they are hired into the organization.
Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.
Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.
Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
Project Management - Communicates changes and progress; Completes projects on time and budget.
Computer Skills: Efficient in Microsoft Word, Excel, and Outlook
To apply for this job email your details to firstname.lastname@example.org