Manager, Clinical Data Management (REMOTE)
Company: Takeda Pharmaceutical
Location: Lodi
Posted on: May 11, 2022
|
|
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. - - ---- -Manager, Clinical Data
Management -The Manager Clinical Data Management is responsible for
timely and high quality data management deliverables supporting the
Takeda portfolio. - They conduct oversight of Data Management
activities at the project level performed by Takeda or Strategic
Partners, CROs or other 3rd Party Vendors - to ensure they meet
obligations as described in ICH-GCP and Takeda's Scope of Work. -
They drive adherence to CDM processes and high ethical standards -
from protocol synopsis through database release and submission. -
-The Manager Clinical Data Management acts as a first point of
contact for CRO partners seeking sponsor input on study level
problem solving and decision making. They contribute to the
management of all study vendors to ensure asset and study level
strategies are being properly - implemented during the conduct of
Clinical Studies as verified in contractual assumptions in study
SOWs (including monthly invoices). - -The Manager Clinical Data
Management serves as an expert for clinical data management best
practices, engages with cross-functional team members to perform
proper Data Reviews and acts as an ambassador on CDISC standards.
------- -Key Accountabilities -* Participates in study level vendor
oversight activities. May 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. - -* Serves as a
first point of contact for CROs partners when collaboration is
needed 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. -* 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. -* 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.
-* Tracks study deliverables and evaluates study metrics to
mitigate risk for major data management deliverables and
milestones. -* 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. -* 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 to functional Continuous Improvement initiatives,
providing expertise and ensuring deliverables are provided on time,
to budget, and 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 4-6 years or
equivalent 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. -* 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. -* Strong
knowledge of FDA and ICH regulations and industry standards
applicable to data capture and data management process. ---- ----
-Special Skills/Abilities -* Good understanding of CDISC standards.
- Some experience in standards development, implementation and
maintenance is ideal. -* Advanced knowledge of office software
(Microsoft Office). -* 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.
---- ---- -Behavioral Competencies -* Pragmatic 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. -* Demonstrated strong matrix leadership
and communication skills. ---- ---- -Job Complexity -* Low-Medium
complexity project. -* Occasional domestic/international travel to
other Takeda sites, strategic partners, and therapeutic area events
may be required. ---- ----Supervision -* Supervision required,
should be able to function collaboratively (with guidance) with all
levels of employees.Base Salary Range: $140,000-160,000 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, Clifton , Manager, Clinical Data Management (REMOTE), Executive , Lodi, New Jersey
Click
here to apply!
|