Sr. Clinical Document Management Specialist at Millennium Pharmaceuticals, Inc. in Lexington, Massachusetts

Job Description:

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Job Description

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, oversee and support, where required, 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.

May perform duties supporting or acting in the role of Designated Clinical Archivist (or backup), such as archival of documents, retrieval of archived documents, tracking and monitoring of documents stored off-site, identifying archived records that have reached the minimum record retention guidelines to determine if destruction is appropriate, and other activities as assigned by CDM management.

Responsible for high quality clinical document deliverables across multiple, global studies assigned in support of CDO ensuring effective lifecycle management of the TMF.

• Key contributor and member of the clinical study team


• Monitors completeness and quality of the Clinical TMF, including elements outsourced to CRO


• Ensures effective communication and issue escalation internally and with external vendors


• Oversees consolidation and archive preparation of the TMF, liaising with CRO partners to ensure compliance with company SOPs and timelines throughout the process

Leads collaboration across R&D to agree to study-specific TMF. Oversees the consolidation of the R&D TMF across functions and external vendors at the end of the study.

Supports inspection readiness for CDO through

• Oversight and support of periodic quality assessments of the TMF


• Monitors clinical records are filed in a timely manner


• With direction from the CDM Team Lead, prepares TMF for agency inspection


• Manages assigned TMF corrective action plans under direction of CDM Team Lead/Manager

Represents CDM by presenting and training on document management processes to functional departments and external vendors.

• Acts as mentor for CDM, providing training and support around clinical document management activities


• Supports CDM-led initiatives to enhance efficiencies in document management

Education and Experience Requirements

• 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


• Advanced computer proficiency


• Experience with use of Electronic Trial Master Systems preferred


• Demonstrated ability to be flexible and to adapt quickly to change


• Ability to multi-task

• Location: Cambridge - Virtual


• Base Salary Range: $77,000-105,000 based on candidate professional experience level. Employee may also be eligible for Short Term and/or Long Term incentive benefits. Employees are eligible to participate in Medical, Dental. Vision, Life Insurance, 401(k), Charitable Contribution Match, Company Holidays, Personal & Vacation Days, Student Loan Repayment Program and Paid Volunteer Time Off


• If candidate is not eligible for any benefits or other comp., those can be excluded

This posting is made in compliance with Colorado’s Equal Pay for Equal Work Act, C.R.S. § 8-5-101 et seq

Locations

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Full time