Senior Clinical Document Management Specialist

Job Title: Senior Clinical Document Management Specialist

Location: Lexington, MA
Duration: 12+ months (possibility of extension)

PRIMARY DUTIES
Reporting to the Clinical Documentation Team Lead, and working in collaboration with the clinical study teams, the Senior Clinical Document Management Specialist is responsible for the management and oversight of Trial Master File (TMF) records from set-up through to final archival of the clinical trial, ensuring compliance with company SOPs and processes, and all applicable regulations.

Focusing on inspection readiness, monitors compliance of the TMF and is responsible for preparation of documentation required for regulatory agency inspection and internal audits.

Oversees set-up and consolidation of outsourced elements of the TMF with preferred CRO vendors. With support from the management team, performs periodic quality assessments of clinical TMF documents where required.

Responsible for delivering assigned Clinical Document Management (CDM) initiatives. Mentors CDM staff on document management process.

DUTIES/RESPONSIBILITIES:

This is a more senior level

Would be doing regular CDM day-to-day activities like:

-Managing studies from start-up to close out

-Working with CRO’s for a large number of studies

-Entire lifecycle management of TMF

-Resolving findings and communicating it to the right people

Senior staffs mentor the regular CDM staff and oversees day-to-day processes

Involved in internal audits and external inspections

Make sure that they know the location of all the documents

Archive Corporation of documents

QUALIFICATIONS:

·Someone with management/mentoring responsibility in the past- a very strong nice to have

·Min. of 5 yrs. Pharmaceutical experience- doesn’t necessarily need to be exclusive to TMF/ CDM experience- must have

·Direct experience (in-depth) with TMF related roles- must have

·Clinical Document Management experience

·Experience with clinical trial can be considered

·Can consider candidates with lots of years of experience in a clinical setting as long as they have in-depth TMF experience

·Experience working with electronic TMF- nice to have

·Minimum 5 years of pharmaceutical industry experience related to clinical document management

·Familiarity with various aspects of clinical trials and regulatory submissions, as well as strong knowledge of document management best practices.

·Current awareness of regulatory requirements for clinical trials (ICH/GCP, FDA, EU Directive).

·Bachelor’s degree or equivalent preferred

KEY SKILLS, ABILITIES, AND COMPETENCIES
• Sufficient knowledge of regulatory requirements and ICH/GCP guidelines to support clinical records management
• Demonstrated ability to work independently, take initiative, complete tasks to deadlines
• Requires strong attention to detail, document organization skills, establishing priorities, scheduling and meeting deadlines
• Solid communication skills and strong customer focus with ability to interact in a global, cross-functional organization
• Ability to communicate effectively with external vendors, including issue escalation, training and responding to inquiries and concerns
• Must be able to work in a fast-paced environment with demonstrated ability to prioritize multiple competing tasks and demands
• Experience mentoring other members of staff preferred
• Experience with use of Electronic Data Management Systems
• Advanced computer proficiency
• Demonstrated ability to be flexible and to adapt quickly to change
Complexity and Problem Solving
• Ability to multi-task
Internal and External Contacts
• Internal study team members within the R&D organization at various levels, global team colleagues; external vendors (CROs, other service providers)
Other Job Requirements
• Full driving license and passport required
• Domestic (within country) and some potential international travel required