Senior Manager, Clinical Data Solutions
Company: Takeda Pharmaceutical
Location: York Springs
Posted on: January 10, 2022
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that all information I submit in my employment application is true
to the best of my knowledge.Job DescriptionSenior Manager, Clinical
Data SolutionsLocation: Cambridge, MA or 100% VirtualAs the Senior
Manager Clinical Data Solutions, you will oversee data management
deliverables supporting the Takeda portfolio. You will report to
the Director of Clinical Data Solutions. You will conduct oversight
of Data Management activities at the program level - as performed
by Strategic Partners, CROs or other 3rd Party Vendors to ensure
they meet obligations as described in ICH-GCP and Takeda's Scope of
Work, maximize effectiveness and maintain budgets.Key
- Oversee vendor oversight activities across global development
programs. Represent data management function on the Clinical
Sub-team ensuring aligned expectations between the CRO and Takeda
for all data related deliverables, especially to support essential
decisions and regulatory submissions.
- Contribute influential leadership in collaboration with other
Takeda Partners to ensure established deliverables are met with the
highest degree of quality.
- Partner with appropriate team members and CRO partners to avoid
and resolve risks.
- Provide input to functional governance with Takeda's strategic
suppliers. Partner with appropriate team members to resolves issues
escalated from the vendor and teams.
- Participate in preparing function for submission readiness and
may represent function in a formal inspection or audit.
- Represent function in formal inspections and audits.
- Ensure archival and inspection readiness of all Data Management
Trial Master File (TMF) documents.
- Ensure achievement of major data management deliverables with
other departments including the Therapeutic Area Units, Clinical
Operations, Statistical Programming and Statistics.
- Manage external Data Management budgets and timelines to ensure
accuracy, understand trends in variances and support continuous
improvement in forecasting.
- May prepare metrics to support the function's Indicators.
- Represent function in external professional plans and
organizations such as SCDM, CDISC, DIA to identify industry best
practice and increase the visibility of Takeda.
- Ensure compliance with own Learning Curricula, corporate and
GXP requirements.Educational Qualifications
- BS/BA in a health-related, life science area or
technology-related fields or equivalent in experience.Experience
- 8 years' data management and drug development process with
expertise in the data management function.
- Project management experience managing data management
activities for large drug development programs.
- Experience with the various phases of development in one or
more therapeutic areas.
- Experience with SDTM
- Experience with eCOA/IRT
- NDA/CTD Experience
- Knowledge of data management best practices and technologies as
applied to clinical trials.
- Experience with clinical trial documents (protocols,
statistical analysis plans, CRFs, study reports) and
- Expert knowledge of FDA and ICH regulations and industry
standards applicable to data capture and data management
- Advanced knowledge of broad drug development process with
expertise in the data management function.
- Knowledge of general medical coding in the
pharmaceutical/biotechnology industry including knowledge of
medical dictionaries, coding tools, and coding governance
- Domestic/international travel (5-20%) to other Takeda sites,
strategic partners, and therapeutic area events may be
required.Location: Cambridge, MA or 100% VirtualBase Salary Range:
$150,000-175,000 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.Effective November 1, 2021,
absent 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. As of the same date, absent an approved
religious or medical reason, US field-based employees, employees
must be fully vaccinated in order to continue in their current
roles. 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. Candidates are encouraged to speak
with their recruiter to seek further information on the applicable
guidelines for the Business Unit/Function for which they have
appliedEEO 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.LocationsBoston, MAWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Ellicott City , Senior Manager, Clinical Data Solutions, Healthcare , York Springs, Maryland
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