Manager, Data Management

Company Information

Clinical ink is the global life science company that brings data, technology, and patient science together to unlock clinical discovery. Our deep therapeutic-area expertise, coupled with Direct Data Capture, eCOA, eConsent, telehealth, neurocognitive testing, and digital biomarkers advancement, drive the industry standard for data precision and usher in a new generation of clinical trials. With offices in Philadelphia, PA, Winston Salem, NC, and Iowa City, IA, Clinical ink is rewriting the clinical development experience.

Job Description

Clinical ink is seeking a Manager, Data Management to join our Data Management team based remotely across the United States! This individual will lead Clinical ink's Data Management team and serve as the primary internal and sponsor contact. The ideal candidate will have extensive data management experience within the pharma, CRO, and/or life sciences industries and the ability to lead a dynamic team. The Manager, Data Management's responsibilities include:

• Serve as the primary internal and sponsor contact for data management questions, issues, or concerns including, but not limited to data collection, data cleaning, data delivery, data reconciliation, database lock and data management activity timelines.
• Lead and oversee the end-to-end data management process within the clinical trials environment.
• Actively engage in data management activities, including reviewing data entry, data validation, and data cleaning processes, to ensure quality and compliance.
• Monitor and work to maintain/improve client satisfaction by ensuring high quality service, communication, and management of source data across the team.
• Lead the development, review, and finalization of data transfer and reporting requirements.
• Manage resourcing through the assignment of studies, tasks, projects, etc.
• Provide oversight of the day-to-day activities to ensure deliverables are met.
• Provide direct oversight and assistance to team members as they carry out their responsibilities, ensuring alignment with project goals and timelines.
• Work across departments to manage customer expectations, improve interdepartmental handoffs, and address escalations within organization.
• Handle both internal and external issue escalations, as needed.
• Assist in peer review/QC of department deliverables.
• Evaluate current processes for efficiency and quality and make recommendations for improvement.
• Direct the process for establishment, review, and adherence of data management processes.
• Develop methods/metrics to assist in measuring department performance and productivity.
• Interview, hire, train, and terminate staff as needed.
• Continuously monitor and evaluate employee performance, quality of deliverables, timeline compliance; provide feedback and guidance when necessary.
  
  

Qualifications

• Bachelor’s degree in Life Sciences or related field preferred.
• Minimum 7 years of clinical data management experience required.
• Minimum of 3 years of management/supervisory experience.
• Certification in Clinical Data Management (e.g., CCDM, CDMP) is a plus.
• Ability to think critically and use good problem-solving skills.
• Experience with data integrations and management tools and platforms, such as SQL & SAS required. Additional knowledge of Snowflake, Python/R nice to have.
• Ability to interact with personnel at all levels.
• Experience creating and maintaining study specific documentation (data export specifications, requirements, change controls, etc.).
• Knowledge of ICH and GCP guidelines.
• Understanding and working knowledge of the structure of clinical trial protocols and how they inform study design.
• Strong knowledge of CDISC standards.
• Strong organizational and time management skills.
• Strong computer skills (e.g. Word, Excel, PowerPoint, etc.)
• Able to function in a fast-paced work environment with superior attention to detail.
  
  

Additional Information

Clinical ink is an equal opportunity employer and does not discriminate against otherwise qualified applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or handicap, or veteran status.

www.clinicalink.com