Senior Clinical Document Management Specialist - REMOTE

Company: Takeda Pharmaceuticals
Location: Albany
Posted on: January 26, 2023

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.**Job Description****_OBJECTIVES/PURPOSE_**The Senior Clinical Document Management Specialist (CDMS) manages and oversees Trial Master File (TMF) compliance from set-up through to final archival of assigned studies, ensuring adherence to operating model(s), SOPs, and applicable clinical trial regulations.+ Collaborates with and acts as a subject matter expert to the Clinical Operations Manager (COM), Clinical Operations Program Lead (COPL), and Study Execution Team (SET) to ensure a complete and accurate TMF through documentation quality, consistency, and process compliance across clinical trials and programs.+ May oversee and/or lead initiatives and process development; Collaborates with CDM management to define TMF health improvement and inspection readiness strategies.+ Supports preparation of documentation required for regulatory agency inspections and internal audits; May stand in front of inspector(s) during inspection.+ Acts as a mentor to CDMTS team members.**_ACCOUNTABILITIES_**Responsible for high quality TMF document deliverables across multiple, global studies ensuring effective lifecycle management of the TMF.+ Supports TMF deliverables and oversight activities, QC planning, TMF health metrics, overall TMF lifecycle management, inspection readiness and preparation.+ Monitors, oversees and manages overall performance of the TMF and TMF processes to ensure/drive TMF compliance and inspection readiness across the organization, including elements outsourced to the 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.+ Supports TMF inspection readiness:+ Oversees and supports periodic quality assessments of the TMF.+ Enforces ownership and accountability across study teams regarding readiness of TMF documents and ensuring clinical records are filed in a timely manner+ Provides education, feedback and support to Study Teams in order to build knowledge and awareness of good document management practices and TMF for clinical trials.+ Independently and with direction from the CDMTS Team Lead, prepares TMF for agency inspections+ Collaborates with Head of Document Management and R&D QA on logistical strategies for complex regulatory inspections+ Independently defines and supports assigned TMF corrective action plans under direction of CDMTS Team Lead/Manager+ Supports the preparation of appropriate audit and inspection responses. Represents CDM by presenting and training on document management processes to functional departments and external vendors.+ Represents CDM by presenting and providing training on document management processes to functional departments and external vendors.+ Acts as a mentor for CDMTS, providing training and support around clinical document management and inspection readiness activities+ Executes CDM-led initiatives to enhance efficiencies in document management+ Initiates and supports 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.+ May perform duties (as assigned by CDM Management) 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.**_CORE ELEMENTS RELATED TO THIS ROLE_**The Senior Clinical Document Management Specialist (CDMS) will manage and oversee Trial Master File (TMF) compliance from set-up through to final archival of assigned studies, ensuring adherence to operating model(s), SOPs, and applicable clinical trial regulations. The Senior CDMS will collaborates with and acts as a subject matter expert to the Clinical Operations Manager (COM), Clinical Operations Program Lead (COPL), and Study Execution Team (SET) to ensure a complete and accurate TMF through documentation quality, consistency, and process compliance across clinical trials and programs. The Senior CDMS may oversee and/or lead initiatives and process development as well as collaborate with CDM management to define TMF health improvement and inspection readiness strategies. The Senior CDMS will support preparation of documentation required for regulatory agency inspections and internal audits; May stand in front of inspector(s) during inspection. The Senior CDMS will acts as a mentor to CDMTS team members.**_DIMENSIONS AND ASPECTS:_**+ Provide expertise in complex Trial Master File Deliverables, Trial Master File structures/eTMF systems, and operating model to study teams.+ Understanding and application of GCP, ICH, and applicable regulatory standards governing clinical research.+ Comfortable with technology and able to learn new systems quickly.+ Strong knowledge of MS Word, Excel, PowerPoint, and Outlook.**Leadership**+ Ability to communicate and influence stakeholders+ Managing deliverables; demonstrating the ability to lead others to drive deliverables forward.+ Navigation of changing priorities and communication about changes.**Decision-making and Autonomy**+ Ability to work in a fast-paced environment with demonstrated ability to manage multiple competing tasks and demands.+ Ability to work with timelines and complete tasks according to deadline.+ Problem solving study-related issues; demonstrating resourcefulness and independence; escalation of issues as needed.**Interaction**+ Must be able to professionally interact and communicate with internal departments (Legal, Insurance, R&D functions, etc.), CROs, and external vendors.+ Ability to effectively collaborate with both internal and external study team.+ Ability to work in a matrix environment.+ Coordination with external vendors as needed.**Innovation**+ Actively identifies continuous improvement opportunities to enhance operational efficiencies through process and metrics analysis.+ Applies lessons learned to continuous improvement of documentation management practices across study teams.+ Knowledge sharing with CDM team as needed.+ Knowledge sharing with study teams as needed.**Complexity**+ Requires strong attention to detail in overseeing/completing TMF Deliverables, TMF Quality Reviews, Metrics/Dashboards, composing and/or approving study materials, establishing priorities, scheduling, and meeting deadlines.+ Ability to take ownership and manage tasks, as well as communicate effectively.+ Assigned clinical studies may be high complexity and/or high risk.+ More than one study and/or more than one program may be assigned.+ Interactions with study teams and other colleagues are both local and remote (in varying locations and time zones).**Education:?**+ Bachelor's degree or equivalent preferred**Experience:?**+ Minimum 3 years' experience in pharmaceutical industry, clinical research organization, or related role.+ Experience in Records management/TMF management and oversight.+ Experience in some capacity in a regulatory agency inspection+ 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).**Skills:**+ Sufficient knowledge of regulatory requirements and ICH/GCP guidelines to support clinical records management+ Clinical Documentation Management and industry experience in order to have a thorough understanding of the processes associated with the conduct of clinical trials and document management operations.+ Demonstrated awareness of sponsor oversight and TMF+ 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+ Strong communication skills and customer focus with ability to interact in a global, cross-functional organization+ Proven 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 Document Management Systems and Electronic Trial Master File Systems, Veeva preferred.+ Advanced computer proficiency+ Demonstrated ability to be flexible and to adapt quickly to change+ Ability to multi-task+ Excellent leadership skills.+ Excellent teamwork, organizational, interpersonal, and problem solving skills.+ Fluent business English (oral and written).**_ADDITIONAL INFORMATION_**+ Full driving license and passport required+ 10% domestic and/or international travel, including overnight and international travel on an as-needed basis**_COMPENSATION_**Base Salary Range: $80,000 -100,000 based on candidate professional experience level. Employee may also be eligible for Short-term and 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._The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience._This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy.**EEO Statement**_Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._**Locations**Massachusetts - Virtual**Worker Type**Employee**Worker Sub-Type**Regular**Time Type**Full time\#LI-Remote

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