Associate Director, Clinical Data Management - Early Oncology - REMOTE
Company: Takeda Pharmaceuticals
Posted on: January 27, 2023
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that all information I submit in my employment application is true
to the best of my knowledge.Job DescriptionREMOTE
OPPORTUNITYAssociate Director, Clinical Data ManagementAs the
Associate Director Clinical Data Management, you are responsible
for timely and high quality data management deliverables supporting
the Takeda portfolio. You will report to the Director, Clinical
Data Solutions. You are responsible for conducting oversight of
Data Management activities at the program, group of programs and/or
portfolio level - as performed within Takeda or 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.You will provide and
enable solutions for complex problem solving that align with the
Takeda values. You will establish Program(s) or Portfolio level
strategies and services, and are accountable for the management of
vendor partnerships to maximize effectiveness and maintain
budgets.You will provide data management expertise and capability
in support of global development programs as well as post-marketing
registration and non-registration studies.Key Accountabilities
- Lead data management activities for in-house and outsourced
studies, and managing staff responsible for performing those
- Manage 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 decisions
and regulatory submissions.
- Provide input to functional governance with Takeda's strategic
suppliers. Partner with appropriate team members to resolves issues
escalated from the vendor and teams.
- For studies where data management activities are conducted
within Takeda, leads clinical trial data collection set-up, data
review, and database lock as follows:
- Works with other departments to complete set up of EDC and
other study data collection tools such as IRT, ePRO and eCOA.
- 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
- Leads data review, including query management, and leads
activities required for interim and final database locks.
- Oversees above activities at the program and portfolio
- 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.
- Accountable for the functional resource coordination to ensure
support for Submission Working Group activities.
- Achieve major data management deliverables with other
departments including the Therapeutic Area Units, Clinical
Operations, Pharmacovigilance and Statistics. This includes
securing and coordinating functional resources to support all
studies within scope to ensure delivery for implementing data
capture tools, Data processing, coding and validation.
- Manage external Data Management budgets (in collaboration with
Clinical Operations TA Leads) to ensure accuracy, understand trends
in variances and support continuous improvement in
- Be a process expert for operational and oversight models.
- Maintain SOPs, process maps and templates and timelines to
support operational and oversight models.
- May prepare metrics to support the function's KPIs.
- Represent function in external professional projects and
organizations such as SCDM, CDISC, DIA to identify industry best
practice and increase the visibility of Takeda.
- Define and Lead functional Continuous Improvement projects,
providing strategic direction and identifying deliverables that
meet timelines, budget, and are company, departmental or functional
- 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
- Bachelors Degree or international equivalent preferred, or
equivalent combination of education, training and
- 8 or more years data management and drug development process
with expertise in the data management function.
- Experience managing vendor relationships and alliance
partnerships with at least 4 years experience in this area.
- Minimum 3 years of line management experience or
- Experience in project management and managing data management
activities for large drug development programs.
- Experience with all phases of development in one or more
therapeutic areas preferred.
- NDA/CTD Experience preferred.
- Experience of data management best practices, standards,
library development and maintenance.
- Experience with clinical trial documents (protocols,
statistical analysis plans, CRFs, study reports) and
- Experience of broad drug development process with expertise in
the interfaces with the data management function.
- Strategic knowledge of FDA and ICH regulations and industry
standards applicable to data capture and data management
- Knowledge of relational databases and experience using multiple
clinical data management systems.
- Knowledge of electronic data capture and data warehouse
technologies as applied to clinical trials.
- Knowledge of general medical coding in the
pharmaceutical/biotechnology industry including knowledge of
medical dictionaries, coding tools, and coding governance
- Ensure adherence to functional budget, and provide updates to
manager regarding additional, potential spend or cost savings.
- Experience of CDISC standards, SDTM and TA-specific standards
preferred. Experience developing internal data standards and
mapping of Medical Concepts is ideal.
- Experience with general medical terminology, medical coding,
laboratory reference ranges, clinical diagnostic procedures,
anatomy/physiology and nature of disease processes.WHAT TAKEDA CAN
- 401(k) with company match and Annual Retirement Contribution
- Tuition reimbursement Company match of charitable
- Health & Wellness programs including onsite flu shots and
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach ProgramsLocation: Cambridge, MA or 100%
VirtualBase Salary Range: $160,000-190,000 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.This position is
currently classified as remote in accordance with Takedas Hybrid
and Remote Work policy.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 Pharmaceuticals, Indianapolis , Associate Director, Clinical Data Management - Early Oncology - REMOTE, Executive , Indianapolis, Indiana
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