Associate Director, Clinical Data Management
Company: Takeda Pharmaceutical
Location: Malden
Posted on: May 13, 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 Privacy Notice and Terms of Use . I further attest
that all information I submit in my employment application is true
to the best of my knowledge.
Job Description
REMOTE OPTION AVAILABLE
OBJECTIVE :
As the Associate Director, Clinical Data Management you will report
to the Director, Clinical Data Solutions and you will ensure the
quality for all Data Management (DM) deliverables globally within a
therapeutic area. You will provide oversight of DM budget in
collaboration with program management. You will provide data
management expertise and capability to support global development
programs and post-marketing registration and non-registration
studies. Contribute to management of strategic vendor partnerships
to maximize effectiveness of external (CRO) resources.
ACCOUNTABILITIES:
Manage vendor oversight activities across all global development
programs within a therapeutic area.
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.
Provide input to functional governance with Takeda's strategic
suppliers.
Partner with appropriate team members to resolves issues escalated
from the vendor.
Ensure achievement of major data management deliverables with other
departments including the Therapeutic Area Units, Clinical
Operations, Pharmacovigilance and Statistics:
Design and implement data capture tools
Data processing, coding and validation
Manage the quality of the data in each database, and quality of
other data management deliverables
Ensure archival and inspection readiness of all Data Management
Trial Master File (TMF) documents
Oversee the planning and management of external Data Management
budgets (in collaboration with Clinical Operations TA Leads) to
ensure accuracy, understand trends in variances and support
continuous improvement in forecasting.
Represent function in external professional projects and
organizations such as SCDM, CDISC, DIA to identify industry best
practice and increase the visibility of Takeda.
Required EDUCATION, EXPERIENCE, LICENSES/CERTIFICATIONS:
Minimum 8 years' data management and/or drug development process
with expertise in the cross-functional interfaces with the data
management function.
Experience managing vendor relationships and alliance partnerships
with at least 4 years' experience in this area.
Minimum 3 years' of line management experience or equivalent
Project management experience 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.
Expert knowledge of data management best practices, standards
library development and maintenance.
Understanding of clinical trial documents (protocols, statistical
analysis plans, CRFs, study reports) and processes.
Knowledge of broad drug development process with expertise in the
cross-functional interfaces with the data management function.
Knowledge of FDA and ICH regulations and industry standards
applicable to data capture and data management process.
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution
Plan
Tuition reimbursement Company match of charitable contributions
Health & Wellness programs including onsite flu shots and health
screenings
Generous time off for vacation and the option to purchase
additional vacation days
Community Outreach Programs
Location: Cambridge, MA or 100% Virtual
Base Salary Range: $160,000-190,000 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.
EEO Statement
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 observing applicable federal, state and local
laws, and any other characteristic protected by law.
EEO Statement
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.
Locations
Massachusetts - Virtual
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Keywords: Takeda Pharmaceutical, Malden , Associate Director, Clinical Data Management, Executive , Malden, Massachusetts
Click
here to apply!
|