Associate Director, Clinical Data Management - REMOTE

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Takeda

Takeda fosters a collaborative and stimulating work environment, filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; gastroenterology, oncology, neuroscience, plasma-derived therapies, rare diseases and vaccines. Boston (Massachusetts) is the R&D headquarters.

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.

Associate Director, Clinical Data Management

The Associate Director Clinical Data Management is responsible for timely and high quality data management deliverables supporting the Takeda portfolio. They are responsible for conducting oversight of Data Management activities at the program, group of programs and/or portfolio level - as performed within Takeda or by Strategic Partners, CROs or other 3rd Party Vendors - to ensure they meet obligations as described in ICH-GCP and Takeda's Scope of Work, maximize effectiveness and maintain budgets.

The Associate Director Clinical Data Management provides and enables solutions for complex problem solving that align with the Takeda values. They establish Program(s) or Portfolio level strategies and services, and is accountable for the management of vendor partnerships to maximize effectiveness and maintain budgets.

The Associate Director Clinical Data Management provides data management expertise and capability in support of global development programs as well as post-marketing registration and non-registration studies.

Key Accountabilities

* Responsible for leading data management activities for in-house and outsourced studies, and/or managing staff responsible for performing those activities.

* Responsible for vendor oversight activities across global development programs. 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.

* Provides input to functional governance with Takeda’s strategic suppliers. Partners with appropriate stakeholders to resolves issues escalated from the vendor and/or cross-functional teams.

* 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.
(d) Oversees above activities at the program and/or portfolio level.

* 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.

* Accountable for the functional resource coordination to ensure support for Submission Working Group activities as needed.

* Accountable for the achievement of major data management deliverables and milestones in coordination with other functions including the Therapeutic Area Units, Clinical Operations, Pharmacovigilance and Statistics. This includes accountability for securing and coordinating functional resources to support all studies within scope to ensure delivery for the Design and implementation of data capture tools, Data processing, coding and validation.

* Accountable for 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.

* Acts as a process expert for operational and oversight models.

* Maintains SOPs, process maps and templates and timelines to support functions operational and oversight models.

* 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.

* Defines and/or Leads functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are 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 8 plus years data management and/or drug development process with expertise in the cross-functional interfaces with the data management function.

* Successful 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.

* Proven track record of strong project management skills 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.

* Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.

* Advanced knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function.

* Strategic knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.

Special Skills/Abilities

* Advanced knowledge of office software (Microsoft Office).

* Strong knowledge of relational databases and experience using multiple clinical data management systems.

* Strong knowledge of electronic data capture and data warehouse technologies as applied to clinical trials.

* Good working knowledge of general medical coding in the pharmaceutical/biotechnology industry including knowledge of medical dictionaries, coding tools, and coding governance models.

* Ensures adherence to functional budget, and provides timely updates to manager regarding additional, potential spend or cost savings.

* Expert knowledge of CDISC standards, SDTM and/or TA-specific standards preferred. Experience developing internal data standards and mapping of Medical Concepts is ideal.

* Advanced knowledge of general of medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology and nature of disease processes.

Behavioral Competencies

* Pragmatic and willing to drive and support change.

* Is comfortable with ambiguity.

* 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

* High complexity at program that include multiple projects and/or platforms.

* Domestic/international travel (5-20%) to other Takeda sites, strategic partners, and therapeutic area events may be required.

Supervision

* Minimal supervision required, should be able to function independently and collaboratively with all levels of employees.

WHAT TAKEDA CAN OFFER YOU:

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.

The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

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.

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