Manager, Clinical Data Management (REMOTE)
Company: Takeda Pharmaceutical
Posted on: May 13, 2022
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Clinical Data Management (CDM) at Takeda
Key to Takeda's success is the Clinical Data Management Team (CDM),
providing strategic planning, resourcing, execution, and oversight
of clinical trial data deliverables. - CDM leads the completion of
clinical trial data deliverables (performed by Takeda or by
vendors) from study start-up through database lock.
CDM performs management & oversight of all study-level data capture
(e.g., EDC, IRT, ePRO, eCOA ) technologies and other related
vendors and/or applications. - CDM engages in strategic
partnerships (when applicable), overseeing expert CROs to ensure
successful execution and delivery of clinical data.
Manager, Clinical Data Management
The Manager Clinical Data Management is responsible for timely and
high quality data management deliverables supporting the Takeda
portfolio. - They conduct oversight of Data Management activities
at the project level performed by Takeda or Strategic Partners,
CROs or other 3rd Party Vendors - to ensure they meet obligations
as described in ICH-GCP and Takeda's Scope of Work. - They drive
adherence to CDM processes and high ethical standards - from
protocol synopsis through database release and submission.
The Manager Clinical Data Management acts as a first point of
contact for CRO partners seeking sponsor input on study level
problem solving and decision making. They contribute to the
management of all study vendors to ensure asset and study level
strategies are being properly - implemented during the conduct of
Clinical Studies as verified in contractual assumptions in study
SOWs (including monthly invoices).
The Manager Clinical Data Management serves as an expert for
clinical data management best practices, engages with
cross-functional team members to perform proper Data Reviews and
acts as an ambassador on CDISC standards.
* Participates in study level vendor oversight activities. May
represents data management function on the Clinical Sub-team
ensuring aligned expectations between the CRO and Takeda for all
data related deliverables, especially in support of key decision
points and regulatory submissions.
* Serves as a first point of contact for CROs partners when
collaboration is needed to ensure established milestones and
deliverables are met with the highest degree of quality.
* Partners with appropriate stakeholders and CRO partners to
mitigate and resolve risks.
* For studies where data management activities are conducted within
Takeda, leads and manages clinical trial data collection set-up,
data review, and database lock:
(a) Works with other functions to complete set up of EDC and other
study data collection tools such as IRT, ePRO and eCOA .
(b) Leads the creation and maintenance of study data cleaning plan
components, including edit checks (data validation plan), listing
review checks, data integration specifications, data transfer
specifications, external data reconciliation plan(s), coding
guidelines, SAE reconciliation guidelines, database lock plans.
(c) Leads data review, including query management, and leads
activities required for interim and final database locks.
* Participates in preparing function for submission readiness and
may represent function in a formal inspection or audit.
* Ensure archival and inspection readiness of all Data Management
Trial Master File (TMF) documents.
* Tracks study deliverables and evaluates study metrics to mitigate
risk for major data management deliverables and milestones.
* Responsible for the planning and management of external Data
Management budgets and timelines to ensure accuracy, understand
trends in variances and support continuous improvement in
* May prepare metrics to support the function's KPIs.
* Represents function in external professional initiatives and
organizations such as SCDM, CDISC, DIA, etc. to identify industry
best practice and increase the visibility of Takeda.
* Contributes to functional Continuous Improvement initiatives,
providing expertise and ensuring deliverables are provided on time,
to budget, and in alignment with company, departmental or
* Works cross-functionally to ensure the quality of the data in
each database and on time delivery, as well as quality of other
data management deliverables.
* Champions and adopts technology improvements and tools for use in
clinical data management processes.
* Ensure compliance with own Learning Curricula, corporate and/or
* Performs other duties as assigned.
* BS/BA required preferably in a health-related, life science area
or technology-related fields.
* Preferred 4-6 years or equivalent experience in data management
and/or drug development process with expertise in the
cross-functional interfaces with the data management function.
* Proven track record of strong project management skills and
experience managing data management activities for large drug
* NDA/CTD Experience preferred.
* Strong knowledge of data management best practices & technologies
as applied to clinical trials.
* Solid understanding of clinical trial documents (protocols,
statistical analysis plans, CRFs, study reports) and processes.
* Strong knowledge of FDA and ICH regulations and industry
standards applicable to data capture and data management
* Good understanding of CDISC standards. - Some experience in
standards development, implementation and maintenance is ideal.
* Advanced knowledge of office software (Microsoft Office).
* Strong knowledge of relational databases and experience using
multiple clinical data management systems.
* Good working knowledge of general medical coding in the
pharmaceutical/biotechnology industry including knowledge of
medical dictionaries, coding tools, and coding governance
* Pragmatic and support change.
* Is comfortable with ambiguity.
* Able to influence without authority.
* Excellent teamwork, organizational, interpersonal, conflict
resolution and problem-solving skills.
* Entrepreneurial and innovative; takes measured risks; thinks
outside the box; challenge the status quo.
* Demonstrated strong matrix leadership and communication
* Low-Medium complexity project.
* Occasional domestic/international travel to other Takeda sites,
strategic partners, and therapeutic area events may be
* Supervision required, should be able to function collaboratively
(with guidance) with all levels of employees.
Base Salary Range: $140,000-160,000 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.
This posting is made in compliance with Colorado's Equal Pay for
Equal Work Act, C.R.S. - 8-5-101 et seq.
This position is currently classified as "remote" in accordance
with Takeda's Hybrid and Remote Work policy.
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.
Massachusetts - Virtual
Keywords: Takeda Pharmaceutical, Bethlehem , Manager, Clinical Data Management (REMOTE), Executive , Reeders, Pennsylvania
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