Clinical Data Manager (Temporary Position, 20 hours/week)

General Summary

The temporary Clinical Data Manager acts as a lead data manager for one or more projects, applies data management experience to clinical trials, and utilizes functional knowledge of the logistics of clinical trials to ensure the quality and integrity of clinical trial data. The CDM works on multi-functional teams and supports clinical trial projects as a departmental subject matter expert (SME).

We are seeking a temporary clinical data manager who can dedicate 20 hours a week to support ongoing study activities. The initial assignment is for 6 months, but may be extended to meet the needs of our Team. Applicants must be eligible to live and work in the US.

Specific Duties and Responsibilities

• Independently lead and/or perform all data management activities within an assigned study (e.g., study startup, study conduct, study closeout, and reporting).
• Serve as the data management SME on multidisciplinary project teams providing specific expertise on timeline development, identification of data management deliverables and resource requirements.
• Participate in the creation, review, and maintenance of project timelines and monitor progress of data management activities.
• Provide oversight for Data Management CRO and other vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, and other relevant guidelines.
• Ensure Data Management documentation is filed/archived according to applicable Penumbra and regulatory requirements.
• Interact with data management, biostatistics, Clinical Affairs and Medical Affairs team to ensure integrity and quality of data.
• Contribute ideas to the development of the department, identifying areas for improvement (e.g., SOPs, processes)
• Participates in audits and inspections.
• Attend Investigator Meetings when requested to provide training on CRF data completion.
• Responsible for creation of training materials and training of the CRAs to ensure consistency of data entry at the sites.
• Provide DM departmental training and to other teams, as needed.
• Utilizes reports to track study progress and ensure timeliness and quality expectations are met.
• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
• Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company.
• Ensure other members of the department follow the QMS, regulations, standards, and procedures.
• Perform other work-related duties as assigned.

Required Qualifications

Minimum education and experience: Bachelor's degree with 5+ years in a medical device, pharmaceutical company, or similar environment (e.g., CRO); or an equivalent combination of education and experience.

Preferred qualifications

• Master’s degree with 3+ years of clinical research, pharmaceutical company preferred
• Thorough knowledge of effective clinical data management practices; CCDM certified professional a plus
• Must have strong experience with systems used for electronic capture of clinical trial data (e.g., iMedidata Rave, InForm, eClinicalOS, RedCap)
• This position must have experience working on regulatory trials within the medical device and/or pharmaceutical industry
• Position requires technical, organizational, analytical, and strong communication skills
• Knowledge of regulatory guidelines pertaining to data quality and data management
• Proven experience and in-depth understanding of all aspects of Data Management
• Ability to effectively manage change and multiple priorities
• Ability to operate independently and achieve results; ability to effectively deal with employees and business contacts and conveys a positive service-oriented attitude
• Knowledge of continuous improvement, project management, change management, and risk management
• Medical device, pharmaceutical, biotech, or other regulated industry experience required
• Proficiency with MS Word, Excel, and PowerPoint