Associate Director, Clinical Data Solutions- Early Oncology
Company: Takeda Pharmaceutical
Location: New Milford
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 and . I further attest that all information I submit
in my employment application is true to the best of my
knowledge.Job DescriptionOBJECTIVE: As the Associate Director,
Clinical Data Solutions 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:
- BS degree in analytical or health-related field.
- 10+ years' of data management experience in the pharmaceutical
industry
- Experience managing vendor relationships and alliance
partnerships with at least 4 years experience in this area
- 3+ years of line management experience.
- Expert knowledge of FDA and ICH regulations and industry
standards applicable to data capture and data management
process.
- Experience with budget planning
- Knowledge of relational databases and experience using multiple
clinical data management systems
- Knowledge of electronic data capture and data warehouse
technologies as applied to clinical trials.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 ProgramsThis Job Posting Excludes CO
ApplicantsEffective 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.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 observing 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.LocationsBoston, MAWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Clifton , Associate Director, Clinical Data Solutions- Early Oncology, Healthcare , New Milford, New Jersey
Didn't find what you're looking for? Search again!
Loading more jobs...