Senior Manager, Clinical Data Management (REMOTE)
Company: Takeda Pharmaceutical
Location: Jersey City
Posted on: May 11, 2022
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Job Description:
By clicking the "Apply" button, I understand that my employment
application process with Takeda will commence and that the
information I provide in my application will be processed in line
with Takeda's and . I further attest that all information I submit
in my employment application is true to the best of my
knowledge.Job DescriptionClinical Data Management (CDM) at Takeda
-Key to Takeda's success is the Clinical Data Management Team
(CDM), providing strategic planning, resourcing, execution, and
oversight of clinical trial data deliverables. - CDM leads the
completion of clinical trial data deliverables (performed by Takeda
or by vendors) from study start-up through database lock. - -CDM
performs management & oversight of all study-level data capture
(e.g., EDC, IRT, ePRO, eCOA) technologies and other related vendors
and/or applications. - CDM engages in strategic partnerships (when
applicable), overseeing expert CROs to ensure successful execution
and delivery of clinical data. - - ---- -Senior Manager, Clinical
Data Management -The Senior Manager Clinical Data Management is
responsible for timely and high quality data management
deliverables supporting the Takeda portfolio. - They are
responsible for conducting oversight of Data Management activities
at the project or program 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. - -The Senior
Manager Clinical Data Management provides and enables solutions for
complex problem solving that align with the Takeda values. - They
establish Project or Program level strategies and services, and are
responsible for the management of vendor partnerships to maximize
effectiveness and maintain budgets. - -The Senior Manager Clinical
Data Management serves as an expert for clinical data management,
whether directly or by way of managing or mentoring other [junior]
CDS Staff. - They will lead cross-functional team members to
perform proper Data Reviews, and provides guidance on CDISC
standards. ---- -Key Accountabilities -* Responsible for leading
data management activities for in-house and outsourced studies; may
manage staff responsible for performing those activities. -*
Responsible for vendor oversight activities across global
development programs. - Represents data management function on the
Clinical Sub-team ensuring aligned expectations between the CRO and
Takeda for all data related deliverables, especially in support of
key decision points and regulatory submissions. - -* Contributes
influential leadership in collaboration with other Takeda
Stakeholders to ensure established milestones and deliverables are
met with the highest degree of quality. -* Partners with
appropriate stakeholders and CRO partners to mitigate and resolve
risks. -* Provides input to functional governance with Takeda's
strategic suppliers. - Partners with appropriate stakeholders to
resolves issues escalated from the vendor and/or cross-functional
teams. -* For studies where data management activities are
conducted within Takeda, leads and manages clinical trial data
collection set-up, data review, and database lock: - - - - (a)
Works with other functions to complete set up of EDC and other
study data collection tools such as IRT, ePRO and eCOA. - - - - (b)
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 plans. - -
- - (c) Leads data review, including query management, and leads
activities required for interim and final database locks. - - - -
(d) May oversee above activities at the program level. -*
Participates 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. -* Ensures achievement of major data
management deliverables and milestones in coordination with other
functions including the Therapeutic Area Units, Clinical
Operations, Statistical Programming and Statistics. -* Responsible
for the planning and management of external Data Management budgets
and timelines to ensure accuracy, understand trends in variances
and support continuous improvement in forecasting. -* Acts as a
process expert for operational and oversight models. -* Maintains
SOPs, process maps and templates and timelines to support functions
operational and oversight models. - -* May prepare metrics to
support the function's KPIs. -* Represents function in external
professional initiatives and organizations such as SCDM, CDISC,
DIA, etc. to identify industry best practice and increase the
visibility of Takeda. -* Contributes or Leads 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.
-* Works cross-functionally to ensure the quality of the data in
each database and on time delivery, as well as quality of other
data management deliverables - - - -* Champions and adopts
technology improvements and tools for use in clinical data
management processes. -* Ensure compliance with own Learning
Curricula, corporate and/or GXP requirements. -* Performs other
duties as assigned. ---- -Educational Qualifications -* 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 development programs. -* 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 function. -Special
Skills/Abilities -* Advanced knowledge of office software
(Microsoft Office). -* Experience with budget planning &
management. -* Strong knowledge of relational databases and
experience using multiple clinical data management systems. -* Good
working knowledge of general medical coding in the
pharmaceutical/biotechnology industry including knowledge of
medical dictionaries, coding tools, and coding governance models.
-* Ensures adherence to functional budget, and provides timely
updates to manager regarding additional, potential spend or cost
savings. -* 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
processes. ---- -Behavioral Competencies -* Pragmatic and willing
to drive and support change. -* Is comfortable with ambiguity. -*
Able to influence without authority. -* Excellent teamwork,
organizational, interpersonal, conflict resolution and
problem-solving skills. -* Entrepreneurial and innovative; takes
measured risks; thinks outside the box; challenge the status quo.
-* Embody a culture of continual improvement and innovation;
promote knowledge sharing . -* Demonstrated strong matrix
leadership and communication skills. ---- -Job Complexity -* Medium
complexity projects, or platforms. -* Domestic/international travel
(5-20%) to other Takeda sites, strategic partners, and therapeutic
area events may be required. ---- -Supervision -* Moderate
supervision required, should be able to function collaboratively
(with some guidance) with all levels of employees. -Base Salary
Range: $150,000-175,000 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.This position is currently
classified as "remote" in accordance with Takeda's Hybrid and
Remote Work policy.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
Keywords: Takeda Pharmaceutical, Jersey City , Senior Manager, Clinical Data Management (REMOTE), Executive , Jersey City, New Jersey
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