Associate Director, Clinical Data Management - Early Oncology - REMOTE
Company: Takeda Pharmaceuticals International GmbH
Posted on: March 19, 2023
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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
- Bachelor's 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.This posting is made in compliance with Colorado's Equal
Pay for Equal Work Act, C.R.S. - 8-5-101 et seq.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 time #LI-Remote
Keywords: Takeda Pharmaceuticals International GmbH, Boston , Associate Director, Clinical Data Management - Early Oncology - REMOTE, Healthcare , Boston, Massachusetts
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