Senior Manager, Clinical Data Solutions
Company: Takeda Pharmaceutical
Location: Jersey City
Posted on: November 18, 2021
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in my employment application is true to the best of my
knowledge.Job DescriptionREMOTE OPPORTUNITYSenior Manager, Clinical
Data SolutionsAs the Senior Manager Clinical Data Solutions, you
will oversees and high-quality data management deliverables
supporting the Takeda portfolio. You will report to the Director,
Clinical Data Solutions of Neuroscience. You will conduct oversight
of Data Management activities at the program 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
mentoring other [junior] CDS Staff. You will lead team members to
perform proper Data Reviews, and provide guidance on CDISC
- Oversee 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 Partners 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 departments 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 operational and oversight models.
- May prepare metrics to support the function's Goals.
- Represent function in external professional plans and
organizations such as SCDM, CDISC, DIA to identify industry best
practice and increase the visibility of Takeda.
- Contribute and lead functional Continuous Improvement plans,
providing strategic direction and identifying important
deliverables that meet timelines, budget, and are with company,
- 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
- 8 years data management and drug development process with
expertise in the interfaces with the data management function.
- Experience with project management managing data management
activities for large drug development programs.
- Experience with all phases of development in one or more
- NDA/CTD Experience preferred.
- Knowledge of data management best practices & technologies as
applied to clinical trials.
- Experience with 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
- Expert in Phase II/Late Phase Neuro studies preferred.Special
- Experience with budget planning & management.
- Knowledge of relational databases and experience using multiple
clinical data management systems.
- Knowledge of general medical coding in the
pharmaceutical/biotechnology industry including knowledge of
medical dictionaries, coding tools, and coding governance
- Expert knowledge of CDISC standards, SDTM preferred. Good
experience leading standards selection and implementing in clinical
trials is ideal.
- Expert knowledge of general of medical terminology, medical
coding, laboratory reference ranges, clinical diagnostic
procedures, anatomy/physiology and nature of disease
- Domestic/international travel (5-20%) to other Takeda sites,
strategic partners, and therapeutic area events may be
required.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 seqEEO
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.LocationsBoston, MAWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Jersey City , Senior Manager, Clinical Data Solutions, Executive , Jersey City, New Jersey
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