Associate Director, Clinical Data Management Compliance and Quality Innovations
Company: Takeda Pharmaceutical
Posted on: August 7, 2022
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Associate Director, Clinical Data Management Compliance & Quality
Innovations - REMOTE
Takeda fosters a collaborative and stimulating work environment,
filled with opportunity and the chance to make a difference in
people's lives. It is a workplace driven by integrity, one of
Takeda s long-held values that extends to both the patients we
serve and our employees who develop and deliver medicines. Across
our company, Takeda employees bring together diverse strengths that
together create a stronger whole.
As one of the world s leading biopharmaceutical companies, Takeda
is committed to bringing Better Health and a Brighter future to
people worldwide. We aspire to bring our leadership in translating
science into life-changing medicines to the next level, in our core
focus areas; gastroenterology, oncology, neuroscience,
plasma-derived therapies, rare diseases and vaccines. Boston
(Massachusetts) is the R&D headquarters.
Associate Director, Clinical Data Management Compliance & Quality
As the Associate Director, Clinical Data Management Compliance &
Quality Innovations you will be accountable for overseeing and
ensuring proper execution of prioritized Clinical Data Management
(CDM) or cross-functional processes related to timely delivery of
quality study Databases (e.g., Quality Gates, Data Review Process).
You will report to the Director, Data Management Operations.
You will partner with the Director of DM Operations, the CDM
Leadership Team and other cross-functional Leaders to identify and
prioritize critical processes requiring oversight to confirm timely
execution, appropriate cross- functional engagement, adequate
reporting of process Compliance & Quality Index level findings to
CDM LT, CDM Leads and other study-level and functional
You will perform continuous evaluation of DM processes and tools to
drive optimization & alignment with R&D ecosystem including,
but not limited to, TAU-specific data Standards deployment,
application (adoption), provide Technical Data Management
perspective across CDM & R&D on relevant quality Dashboards,
collect and share best practices for Data quality.
- Lead data management process oversight and ensuring proper
execution of prioritized Clinical Data Management (CDM) or
cross-functional processes related to timely delivery of quality
study Databases (e.g., Quality Gates, Data Review Process), and/or
managing staff responsible for performing those activities.
- Perform routine evaluation of processes to determine adherence
to procedural documentation, active process engagement by study
team functional representatives, and adherence to study milestone
- Manage TAU-specific data Standards deployment, application
(adoption), and fit for purpose from a Clinical Data Management
- Develop KPIs, metrics and quality dashboards to track process
quality, efficiency and compliance
- Engage with CDM Study Leads to provide feedback on study team
performance on evaluated processes
- Recruit and manage a team of Compliance & Quality Innovation
specialists, and coordinate deployment to various TAUs or Study
teams based on portfolio priorities
- Act as a process expert for operational and oversight
- Maintain SOPs, process maps and templates and timelines to
support functions operational and oversight models.
- Prepare metrics to support the function s KPIs.
- Represent function in external professional initiatives and
organizations such as SCDM, DIA, etc. to identify industry best
practice and increase the visibility of Takeda.
- Define and Lead functional Continuous Improvement initiatives,
providing strategic direction and identifying key deliverables that
meet timelines, budget, and are in alignment with company,
departmental or functional requirements.
- Work to ensure the quality of the data in each database and on
time delivery, as well as quality of other data management
- Champion and adopt technology improvements and tools for use in
clinical data management processes.
- Ensure compliance with own Learning Curricula, corporate and/or
- BS/BA in a health-related, life science, quality assurance or
instructional design areas or technology-related field preferred or
equivalent combination of education, training and experience
- Minimum 8 years' experience in clinical data management,
compliance, or quality management.
- Minimum of 3 years of line management experience or
- Project management experience managing data management coding
activities for large drug development programs.
- Experience with GCP, regulatory and ICH guidelines as
applicable to clinical data management; clinical experience in one
or more of the following therapeutic areas desired: cell therapy,
oncology, GI, Neuroscience, PDT, Rare disease, Vaccines and/or
- Experience managing multiple development programs
- NDA/CTD Experience preferred.
- Experience with clinical trial documents (protocols,
statistical analysis plans, CRFs, study reports) and
- Experience with broad drug development process with expertise
in the cross-functional interfaces with the data management
- Experience with FDA and ICH regulations and industry standards
applicable to data capture and data management process.
- Advanced knowledge of office software (Microsoft Office).
- Strong knowledge of relational databases and experience using
multiple clinical data management systems.
- Strong knowledge of electronic data capture and data warehouse
technologies as applied to clinical trials.
- Experience developing internal data standards is ideal.
- Advanced knowledge of general of medical terminology, medical
coding, laboratory reference ranges, clinical diagnostic
procedures, anatomy/physiology and nature of disease
High complexity at program that include multiple projects and/or
Domestic/international travel (5-20%) to other Takeda sites,
strategic partners, and therapeutic area events may be
Minimal supervision required, should be able to function
independently and collaboratively with all levels of employees.
WHAT TAKEDA CAN OFFER YOU:
- 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 Programs
Location: Cambridge, MA or 100% Virtual
Base 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
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, Revere , Associate Director, Clinical Data Management Compliance and Quality Innovations, Healthcare , Revere, Massachusetts
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