Sr. Manager, Clinical Data Solutions
Company: Takeda Pharmaceutical
Posted on: May 9, 2022
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knowledge.Job DescriptionTakedaTakeda 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 TakedaKey
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 ManagementAs 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.Key
- 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 resolve risks.
- 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
- Work to ensure the quality of the data in each database
delivery, and quality of other data management
- BS/BA required preferably in a health-related, life science
area or technology-related fields.Experience
- 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
- 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
- Expert knowledge of FDA and ICH regulations and industry
standards applicable to data capture and data management
- Advanced knowledge of broad drug development process with
expertise in the cross-functional interfaces with the data
management function.Location: Cambridge - VirtualBase 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 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.LocationsLexington, MAWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Passaic , Sr. Manager, Clinical Data Solutions, Executive , Passaic, New Jersey
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