Manager, Clinical Data Solutions Early Oncology
Company: Takeda Pharmaceutical
Posted on: May 14, 2022
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in my employment application is true to the best of my
knowledge.Job DescriptionAs the Manager Clinical Data Management,
you will manage data management deliverables supporting the Takeda
portfolio. You will 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. You will bring
adherence to CDM processes from protocol synopsis through database
release and submission.You will be the first contact for CRO
partners looking for sponsor input on study level problems. You
will contribute to the management of all study vendors to ensure
asset and study level strategies are being implemented during the
conduct of Clinical Studies as verified in contractual assumptions
in study SOWs (including monthly invoices).You will be an expert
for clinical data management best practices, engage with team
members to perform proper Data Reviews and acts as an ambassador on
CDISC standards.Key Accountabilities
- Participate 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 to support important
decisions and regulatory submissions.
- Be a first contact for CROs partners when collaboration is
needed to ensure established deliverables are met with the highest
degree of quality.
- Partner with appropriate team members and CRO partners to
reduce and resolve risks.
- For studies where data management activities are conducted
within Takeda, 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.
- Participate 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.
- Track study deliverables and Evaluate study metrics to mitigate
risk for major data management deliverables.
- 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
- Represent function in external professional projects and
organizations such as SCDM, CDISC, DIA to identify industry best
practice and increase the visibility of Takeda.
- Contribute to functional Continuous Improvement plans,
providing expertise and ensuring deliverables are provided on time,
to budget, and with company, departmental or requirements.
- Ensure the quality of the data in each database delivery, and
quality of other data management deliverables
- Champion and adopt technology improvements and tools for use in
clinical data management processes.
- Ensure compliance with own Learning Curricula, corporate and
GXP requirements.Educational Qualifications
- BS/BA required preferably in a health-related, life science
area or technology-related fields.Experience
- 4+years or equivalent experience in data management and drug
development process with expertise in the interfaces with the data
- Experience with project management and managing data management
activities for large drug development programs.
- NDA/CTD Experience.
- Knowledge of data management best practices & technologies as
applied to clinical trials.
- Experience with clinical trial documents (protocols,
statistical analysis plans, CRFs, study reports) and
- Knowledge of FDA and ICH regulations and industry standards
applicable to data capture and data management process.Location:
Cambridge OR VirtualBase Salary Range: $120,000-140,000 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. If candidate is not eligible for any benefits
or other comp., those can be excludedThis posting is made in
compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. -
8-5-101 et seqAbsent 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.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
Keywords: Takeda Pharmaceutical, Lowell , Manager, Clinical Data Solutions Early Oncology, Executive , Lowell, Massachusetts
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