Sr. Manager, Clinical Information Operations-IRT Lead
Company: Takeda Pharmaceutical
Posted on: May 13, 2022
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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 DescriptionTitleSr. Manager Clinical Information
Operations IRT LeadLocationLexington, MA or 100% VirtualOverviewCDS
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, and oversight of all Study-level data capture (e.g.,
EDC, IVR, ePRO, eCOA, CDW) technologies and other related vendors
and applications.As the Clinical Information Operations Sr.
Manager, reporting to the Head of Clinical Information Operations,
you will participate in, and provide leadership for the following
- Develop strategy for technology selection and deployment across
Clinical Studies with established Takeda SOPs and Policies, and
- Implement new integrations or upgrades to existing IRT
platforms for Takeda studies. You will ensure that this activities
are performed in GCP compliant way. You will make sure that the
system provides intended functionality and appropriate processes
are developed to support clinical trial.
- Identify new cost-effective IRT solutions to support clinical
program goals. You will work with business representatives from
study teams, CROs, vendors and Clinical Supplies organization to
ensure delivery of solutions.
- Manage a team of contractors to ensure daily administration of
IRT platforms. Working with partners to guide adoption and
optimization of implementation of IRT for clinical trials.
- Coordination and participation with external parties (Vendors
- Participate in IRT vendor governance meetings to review Goals
and Service level agreements.
- Oversee system delivery life cycle, including deployment
strategies, user training and management.
- Be a process expert for operational and oversight models.
- Confirm archival and inspection readiness of all Clinical
Technology Trial Master File (TMF) documents.
- Participate in preparing function for submission readiness and
may represent Clinical Information Operations (CIO) group in a
formal inspection or audit.
- Establish major data management study deliverables and develop
study metrics, and monitor risk mitigation plans.Educational
QualificationsBS/BA required or MS preferred in a health-related,
life science area or technology-related fields.Experience
- Minimum of 8 years drug development experience.
- Experience with clinical trial documents (protocols,
statistical analysis plans, CRFs, study reports) and
- Solid system admin expertise, user support experience in
multiple types of clinical technologies: electronic Clinical
Outcome Assessment (eCOA), electronic Patient Reported Outcome
(ePRO), Interactive Voice/Web Response System (IxRS), Electronic
Data Capture (EDC), Clinical Data Wearhouse, or Clinical Trial
Management System (CTMS).
- Project management experience managing implementation of
Clinical Data Wearhouse for large drug development programs.
- Experience with all phases of drug development.
- Solid experience applying System Development Life Cycle (SDLC)
and developing strategies to address required changes to clinical
trial technologies because of evolving GXP regulations.
- Knowledge of FDA and ICH regulations and industry standards and
quality control principles.Base Salary Range: $140,000-170,000
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. - - -This posting is made in
compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. -
8-5-101 et seq.Effective November 1, 2021, 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. As of the same date, absent an approved religious or
medical reason, US field-based employees, employees must be fully
vaccinated in order to continue in their current roles. 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. Candidates are encouraged to speak with their
recruiter to seek further information on the applicable guidelines
for the Business Unit/Function for which they 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.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.LocationsIllinois - VirtualWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Hoboken , Sr. Manager, Clinical Information Operations-IRT Lead, Healthcare , Hoboken, New Jersey
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