Manager, Clinical Document Management - REMOTE
Company: Takeda Pharmaceuticals
Location: Washington
Posted on: January 27, 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 Takedas 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 DescriptionOBJECTIVE/PURPOSEThe
Clinical Document Manager is responsible for management of assigned
Clinical Document Management Specialists (CDM) ensuring optimal use
of resources and skillsets to deliver effective clinical document
and Trial Master File (TMF) lifecycle management and support for
Global Development Op-erations (GDO). The CDM Manager will be
responsible for direct line management, ensuring appropriate
training and oversight to ensure consistent and high-quality trial
support across programs.Partners with Head of CDM and R&D
Functional Area representatives to execute strategies and
depart-mental goals in relation to TMF and Records management for
Takedas global portfolio. Acts as CDM project lead and subject
matter expert to oversee execution complex projects (e.g.,
integrations and divestments, process optimization, eTMF
strategies, processes and reporting.With a focus on inspection
readiness for TMF, supports and may serve as TMF Lead for,
activities in preparation for regulatory inspections and
audit.ACCOUNTABILITIES:In collaboration with Head of CDM, ensures
effective CDM resourcing to support clinical document and Trial
Master File (TMF) lifecycle management and support across the trial
porfolio. Ensures consistency with CDM support and compliance
across projects. Contributes to development of and leads assigned
departmental objectives, representing CDM globally. Develops and
implements clinical document processes to enhance support and
com-pliance.Acts as CDM lead to support complex activities (e.g.,
company acquisition and eTMF optimization projects) Manages day to
day activities of the assigned staff providing guidance, coaching
and supporting issue escalation. Motivates the team to achieve
organizational goals, delegating tasks and implementing timelines
to achieve targets to ensure high quality service and outstanding
stakeholder support. Ensures all employees receive appropriate
training and education. Empowers team members with skills to
support development growth and subject matter expertise. Supports
team to successfully achieve individual business and development
goals supporting issues and providing guidance on a day to day
basis Provides informal feedback on an ongoing basis and formally
in the annual performance evaluation process to support continued
development growth Contributes to staffing for CDMTS through the
appropriate hiring, performance management and succession
planningPromotes a positive, results-driven environment which
models teamwork and provides visibility into suc-cesses.With a
focus on inspection readiness, monitors CDM compliance of the
clinical TMF and lifecycle man-agement of TMF records. Monitoring
compliance of clinical document management deliverables and
overseeing re-sources in the execution of inspection readiness
plans. May serve as TMF Inspection Lead for regulatory inspections
of Takeda, resposible for ensuring execution of IR strategy and
presentation/SME of TMF Process to inspectorate. Provides subject
matter expertise, guidance and training to functional teams at all
levels. Participates in workgroups for SOP and process
optimization. Supports corrective and preven-tative actions
identified through audit. May lead selected clinical records
activities in collaboration with CDM.CORE ELEMENTS RELATED TO THIS
ROLE The Clinical Document Manager manages a team of Clinical
Document Management specialists, en-suring optimal use of resources
and skillsets to deliver effective Trial Master File lifecycle
manage-ment and support across a large portfolio. Contributes to
development of and leads departmental projects in support of
company goals and pro-cess optimization and efficiency. Serves as
subject matter expert and leads complex projects working in
collaboration with other functional Managers. The Clinical Document
Manager supports inspection readiness for Takeda leading execution
of strategies and resources and may serve as TMF Lead, preparing
and presenting to the inspectorate.DIMENSIONS AND ASPECTS: Provide
expertise in complex Trial Master File Deliverables, Trial Master
File structures/eTMF systems, and operating model to study teams.
Current awareness, 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 eTMF (Veeva Vault preferred) and Microsoft
applications.Leadership (Vision, strategy and business alignment,
people management, communication, influencing others, managing
change) 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. Leads team in manner which motivates,
provides stretch goals and supports a culture of continued personal
growth and development within Takeda. Decision-making and Autonomy
(The capacity and authority to make organizational decisions,
autonomy in decision-making, complexity of decisions, impact of
decisions, problem-solving) Ability to work in a fast-paced
environment with demonstrated ability to manage mulitple competing
tasks and demands. Problem solving study-related issues;
demonstrating resourcefulness and independence; escalation of
issues as needed.Interaction (The span and nature of ones
engagement with others when performing ones job, internal and
external re-lationships) Must be able to professionally interact
and communicate with internal departments at all levels of the
organization internally and with external vendors.Innovation (The
required level of scientific knowledge, knowledge sharing,
innovation and risk taking) Actively identifies continuous
improvement opportunities to enhance operational efficiencies
through process and metrics analysis and audit outcomes.
Participates in workstreams which contribute to the development,
implementation and successful adoption of R&D systems and
processes.Complexity (Products managed, mix of businesses, internal
and/or external business environment, cultural considerations)
Overseeing TMF deliverables and for a large cross-therapuetic
portfolio. Optimizing the resources and skill sets of a team to
deliver targets and work in a cross functional setting on trial
execution Interactions with cross functional teams and business
units including Senior program or function management. Composing
and approving process documentation, establishing priorities,
scheduling, and meeting deadlines. Supporting inspections and
directly presenting to inspectorate. Ability to take ownership and
manage tasks, as well as communicate effectively. Working on
multiple assigned projects which may be complex and/or high
risk.EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS Education:
Bachelors degree or equivalent preferred Experience: Minimum 5
years plus experience in pharmaceutical industry, clinical research
organization, or related role. Strong knowledge in TMF and records
management and oversight. Experience in regulatory agency
inspection(s) Understanding of ICH/GCP and other application
reguations pertaining to Trial Master File management for clinical
trials and regulatory submissions. Skills: 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 or supervising other members of staff in some
capacity, direct line management 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
Excellent teamwork, organizational, interpersonal, and problem
solving skills.COMPENSATIONBase Salary Range: $102,000 - 146,000
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
Takedas Hybrid and Remote Work policy.EEO StatementTakeda 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.LocationsMassachusetts -
VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull
time#LI-Remote
Keywords: Takeda Pharmaceuticals, Washington DC , Manager, Clinical Document Management - REMOTE, Healthcare , Washington, DC
Click
here to apply!
|