Senior Clinical Data Manager, Senior Clinical Study Manager
Location: Nationwide, NJ, USA, NJ
Name: Lu Cheng
TechData is looking for Biostatistician (some positions are remote), Statistical Programmer (some positions can be telecommuting), CDISC programmer/Sr. SAS Programmer Analyst, Sr. Clinical Study Manager, Sr. Clinical Outsourcing Consultant, Sr. Medical Data Specialist/Medical Dictionary Coding, Sr. Clinical Data Manager, and Medical Writer for our pharmaceutical clients in multiple locations in Northern NJ. We also have similar positions in MA, MD, NC, PA, and CA. Please see the requirements below and send your resume to: lu.cheng[Click Here to Email Your Resumé]. TechData is a leading provider for temporary and permanent positions in the pharmaceutical industry. TechData offers the most competitive pay rates and benefits in clinical research consulting services.
Sr. Clinical Study Manager
- Identify and select high-quality clinical vendors in conjunction with the appropriate team members by interviewing and assessing a vendor’s skill set. Work with the contracting/budgeting team to ensure that vendor responsibilities and payment terms are clearly defined.
- Manage and effect oversight of assigned clinical vendors and functional service providers to ensure data integrity and adherence with regulatory requirements. Assure that team is receiving high quality, on time deliverables from internal and external vendors.
- Collaborate with other team members to coordinate the development and finalization of key study documents including protocols, case reports forms, informed consent documents, study management plans and final clinical study reports.
- Manage multiple projects and lead multiple study teams simultaneously. Monitor studies against defined milestones and timelines to assure that all deliverables are met. Facilitate the development and implementation of remedial activities when necessary. Attend weekly teleconference with CRO (if applicable). Assume monitoring, co-monitoring responsibilities as needed.
- Communicate with Principle Investigator, Study Co-Coordinator, and/ CRO (if applicable) to proactively recognize problem situations and work with other team members as required to resolve issues
- Manage the publication process in conjunction with the publications team to assure that submission timelines are met.
- Monitor and report clinical trial status using standard and adhoc review & reporting procedures and identify issues that affect functions. Ensure that each function is accountable for their deliverables.
- In collaboration with Project Management and utilizing various tracking mechanisms, manage clinical trial project milestones and budget. Proactively identify issues and escalate to appropriate managers.
- At least 7 years of experience in the management of clinical trials, significant knowledge of overall clinical drug development and general clinical research operations.
- Pharma industry a MUST – Open to some CRO but pharma ONCOLOGY EXPERIENCE REQUIRED.
- Ability to manage multiple projects simultaneously with strong organizational and planning skills.
- Well-developed analytical and problem solving skills. Communicates issues to Director with action plans for resolution.
- Knowledgeable in all required regulatory and compliance standards and guidelines including ICH-GCP.
- Ability to effectively work with teams and promote collaborations. Exceptional interpersonal skills including the ability to influence negotiate and resolve conflicts.
- Excellent verbal and written communication skills and the ability to interact with all levels of management within the organization and to external business contacts.
- Experience using the Inform database, PowerPoint and Excel software.
- Independent judgment and decision making skills with respect to functional responsibilities.
- Innovative and motivated in optimizing clinical operations processes to meet deliverables.
BS or BA in related field, focusing on biological science, nursing or equivalent is preferable. Advanced Degree preferred.
Senior Clinical Data Manager
- Perform DM activities in-house: protocol review, CRF development, database set up activities, data validation process (including manual data review of listings), SAE reconciliation, managing local laboratory and external labs and database lock.
- Perform Project Management: represent DM on clinical teams, coordinate deliverables by other functions and/or CRO as necessary to achieve DM deliverables.
- Coordinate with Programming team to provide support to the data review and safety updates (coordinate generation of data review listings, data retrieval to support data review and analysis, SDTM,)
- Coordinate CRO data validation activities (coordinate data transfer specs, data reconciliation, query generation and resolution,
- Participate in the development and implementation of department standards and documents, and other data management, departmental activities as needed.
- Minimum 5 years’ experience in Data Management with some experience in managing projects, project teams
- Experience in handling local labs, external data
- Experience in managing CRO, global team
- Experience with In-Form or other EDC software is desirable however, should have some experience in supporting Oncology studies
Ideal candidate possesses the strengths in the above description, but also the ability to be independent, the ability to determine when critical issues should be escalated to their superior, and the ability to propose sensible solutions.