Manager, Clinical Data Management (REMOTE)

Company: Takeda Pharmaceutical
Location: Reeders
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
Clinical 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 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, Bethlehem , Manager, Clinical Data Management (REMOTE), Executive , Reeders, Pennsylvania