Manager, Clinical Document Management - REMOTE
Company: Takeda Pharmaceutical
Location: Newark
Posted on: January 23, 2023
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Job Description:
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Job Description
OBJECTIVE/PURPOSE
The 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 Takeda's 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 planning
Promotes 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 one's engagement with others
when performing one's 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: Bachelor's 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.
COMPENSATION
Base 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.
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Keywords: Takeda Pharmaceutical, Newark , Manager, Clinical Document Management - REMOTE, Executive , Newark, New Jersey
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