Clinical Data Manager II (Medical Devices) - Intellectt INC

Role: Clinical Data Manager II

Location: Princeton, NJ - 8540

Duration: 06 Months

Summary:

The Lead Clinical Data Manager is responsible for performing data management tasks within defined established processes throughout the life cycle of the study, including startup, conduct and close phases. The Lead Clinical Data Manager will independently perform all data management functions to ensure timely and quality database lock for studies conducted in-house and offshore CRO. The position will also develop and maintain working practice documents for all Data Management tasks in collaboration with representatives from other functions. The position acts as DM resource to the Clinical Study team and guides the team in the coordination of clinical data review, query generation / resolution and reconciliation activities. The position also supports the Director, Clinical Data Management in ensuring the delivery of clinical data in compliance with standard operating procedures, departmental guidelines and regulatory agency guidelines.

Job Description:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Act as the point of contact for DM activities for multiple studies, provide oversight of data collection and management per regulatory and industry standards.

Contribute to the finalization of Protocols for proper data collection including Electronic Case Report Form design.

Develop and maintain all required data management documentations such as edit check specifications, eCRF Completion Guidelines, Data Management Plans, etc.

Review eCRFs to ensure alignment with protocol and perform UAT testing to ensure database structure meets expectations and provide DM insight to promote effective clinical database structure.

Proficient in performing data quality checks to clean data for assigned studies. Proactively identify and implement opportunities for process improvement of assigned responsibilities.

Provide oversight of the DM activities and key DM documentations from CRO(s) and ensure performance against key indicators and the documentation is aligned with best practices and provide DM expertise to study teams.

Drive and support vendor qualification for data management, define/specify scope of work for functional tasks.

Support process improvement and knowledge management by participating in or leading task forces/projects

Demonstrate effective time management skills and able to set priorities to meet timelines. Be able to recognize and schedule changes in response to project demands

Provide guidance and mentor less experienced Data Management professionals.

Qualifications:

The requirements listed below are representative of the knowledge, skill and/or ability required for his position.

• Education: Bachelor's degree in science and/or equivalent work experience in data management field.
• Experience: A Minimum of 5+years of working experience in pharmaceutical, biotechnology, medical device/diagnostic or CRO setting with significant hands-on end-to-end experience in clinical data management practices.
• Strong experience leading data management activities for multiple clinical studies, proficient use of data management systems, advanced knowledge of DM processes, tools, methodologies and documentation, solid understanding of DM strategy.
• The preferred candidate must have strong writing, verbal communication skills, good organizational, time management skills, interpersonal and team skills, and be proactive and accountable.

TOOLS AND EQUIPMENT USED:

• Experience utilizing Veeva CDMS system and Veeva Vault eTMF.
• Ability to utilize a computer, telephone, fax and copy machine as well as other general office equipment.
• Strong computer skills are required.