Senior Clinical Document Management Specialist - REMOTE
Company: Takeda Pharmaceuticals
Location: Albany
Posted on: January 26, 2023
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Job Description:
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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
Keywords: Takeda Pharmaceuticals, Albany , Senior Clinical Document Management Specialist - REMOTE, Executive , Albany, New York
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