Associate Director, Clinical Records Management
Company: Takeda Pharmaceutical
Location: Claymont
Posted on: August 7, 2022
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 As the AD/Sr. Manager,
Clinical Records Manager, you will oversee management of Takeda's
clinical records in archive state to ensure compliance with
regulatory requirements and Takeda policy, support preservation and
retrieval of records to support Takeda business activities. Serving
as subject matter expert for records management, you will
contribute to the company and department goals, through management
of programs and process development in collaboration with CDM
Leadership, third-party archive vendors and team members. You will
support inspection readiness for Takeda leading execution of
strategies to provision records for audit and as subject matter
expert, and presents to the inspectorate.ACCOUNTABILITIES:
- Collaborate with representatives and external partners to
support retention and accessibility of clinical records that have
reached archive status to support Takeda's records management
policies, regulatory filings, submissions, acquisitions and
divestments.
- Maintain the operations of the physical records room(s)
regarding archiving, indexing and retrieval of essential physical
records. This also includes the management of clinical records held
globally across Takeda external vendor off-site facilities.
- Maintain electronic records with Takeda content management
system(s) and third-party databases.
- Ensure appropriate tracking to ensure efficient identification
of clinical records across a network of systems and
locationsContribute to company and department goals and
define/leads plans which help improve clinical records management,
including records consolidation project(s); oversee delivery of
clinical records to support divestment projects, annual destruction
and retention reviews.Develop clinical records management
procedures.Support preparation of documentation required for
regulatory agency inspections and internal audits. May stand in
front of inspector(s) during inspection.Provide high-quality
customer service and record assistance through all levels. In
collaboration with Head of Clinical Document Management, outlines
proposals to gain senior management approval for budget and
resources to support plans to improve compliance and efficiency in
clinical records management.Manage daily activities of the assigned
staff providing training and supporting issue escalation.
- Support team to achieve individual business and development
goals.
- Provide feedback on an ongoing basis to support continued
development growth.EDUCATION, BEHAVIOURAL COMPETENCIES AND
SKILLS:Education:
- Bachelor's degree or equivalentExperience:
- 8+ years' experience in pharmaceutical industry, clinical
research organization, or records management related role.
- Demonstrated experience in managing direct reports and/or
supervising team
- Current awareness of regulatory requirements for clinical
trials (ICH/GCP) pertaining to records management preferred.Skills:
- Ability of records management program. Experience in
pharmaceutical records management and understanding of associated
regulatory requirements.
- Communicate with external vendors, including issue escalation,
training and responding to inquiries and concerns
- Experience with use of Electronic Records Management
Systems
- Leadership experienceAbsent an approved religious or medical
reason, all US office-based and lab-based Takeda employees who work
fully on-site or in a hybrid model (as determined by Takeda) must
be fully vaccinated to work at a Takeda site or to engage with
Takeda colleagues or anyone else on behalf of Takeda. US
field-based employees must be fully vaccinated as a condition of
employment, absent an approved religious or medical reason. US
employees who work at a Takeda manufacturing facility, and those
who work at a BioLife center or BioLife lab, may be subject to
different guidelines. If you are contacted by a Takeda recruiter
about your job application, we encourage you to seek more
information on the applicable guidelines for the Business
Unit/Function to which you have applied.In accordance with the CO
Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.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 North Carolina - Virtual Worker Type Employee Worker
Sub-Type Regular Time Type Full time
Keywords: Takeda Pharmaceutical, Philadelphia , Associate Director, Clinical Records Management, Executive , Claymont, Pennsylvania
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