Sr. Manager, Clinical Data Solutions
Company: Takeda Pharmaceutical
Location: Little Ferry
Posted on: May 12, 2022
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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.
Clinical Data Solutions (CDS) at Takeda
Key to Takeda's success is the Clinical Data Solutions Team (CDS),
providing Strategic planning, resourcing and oversight of clinical
trial data deliverables.
CDS engages in strategic partnerships, overseeing expert CROs to
ensure successful execution and delivery of Clinical Data. CDS also
owns Takeda's strategy for the development and governance of Data
Standards, with the CDISC (Clinical Data Interchange Standards
Consortium) industry standards. CDS performs oversight of all
Study-level data capture (e.g., EDC, IVR, ePRO, eCOA) technologies
and other related vendors and applications.
Senior Manager, Clinical Data Management
As the Senior Manager Clinical Data Management, you will oversees
and high-quality 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 project 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.
You will be an expert for clinical data management, whether
directly or by way of managing other [junior] CDS Staff. You will
lead team members to perform proper Data Reviews, and provide
guidance on CDISC standards.
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 essential
decisions and regulatory submissions.
Contribute influential leadership in collaboration with other
Takeda Team members to ensure established deliverables are met with
the highest degree of quality.
Partner with appropriate team members and CRO partners to avoid and
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
teams 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.
Be a process expert for operational and oversight models.
Maintain SOPs, process maps and templates and timelines to support
departments operational and oversight models.
May prepare metrics to support the function's Goals.
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 or lead functional Continuous Improvement plans,
providing strategic direction and identifying essential
deliverables that meet timelines, budget, and are with company,
departmental or requirements.
Ensure compliance with own Learning Curricula, corporate and GXP
Work to ensure the quality of the data in each database delivery,
and quality of other data management deliverables
BS/BA required preferably in a health-related, life science area or
Preferred 6-8 years or equivalence experience in data management
and/or drug development process with expertise in the
cross-functional interfaces with the data management function.
Proven track record of strong project management skills and
experience managing data management activities for large drug
Experience with all phases of development in one or more
therapeutic areas preferred.
Ability to handle multiple development programs simultaneously.
NDA/CTD Experience preferred.
Strong knowledge of data management best practices & technologies
as applied to clinical trials.
Solid understanding of clinical trial documents (protocols,
statistical analysis plans, CRFs, study reports) and processes.
Expert knowledge of FDA and ICH regulations and industry standards
applicable to data capture and data management process.
Advanced knowledge of broad drug development process with expertise
in the cross-functional interfaces with the data management
Location: Cambridge - Virtual
Base Salary Range: $150,000-170,000 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 excluded
This posting is made in compliance with Colorado's Equal Pay for
Equal Work Act, C.R.S. - 8-5-101 et seq
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. 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.
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.
Keywords: Takeda Pharmaceutical, Clifton , Sr. Manager, Clinical Data Solutions, Executive , Little Ferry, New Jersey
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