Back

Associate Director, Clinical Data Management Medical Coding (REMOTE)

Bio-Life Plasma, LLC

Money Icon
$68.99 /h
PAY RATE
Location Pin Icon
Boston, MA
LOCATION

Job Description

As posted by the hiring company

Job Overview:

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

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 (CDM) Coding

The Associate Director, CDM Coding is responsible for the delivery of timely and quality coding deliverables for clinical trials and programs. This position will develop and implement a long-term coding strategy to ensure that Takeda meets industry and regulatory requirements for clinical trial coding.

The Associate Director, CDM Coding will manage and oversee Takeda staff, strategic partners, and vendors who conduct coding activities. They are responsible for conducting oversight of Data Management Coding 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, CDM Coding 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, CDM Coding provides coding 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 coding activities for in-house and outsourced studies, and/or managing staff responsible for performing those activities.

  • Leads clinical trial coding deliverables and activities that support Takeda regulatory commitments including submission of safety data.

  • Serves as a medical coding subject matter expert.

  • Partners with stakeholders to optimize technology that supports efficient dictionary management processes and oversight of vendor coding quality.

  • In collaboration with Takeda’s Global Coding Committee develops, implements, and evaluates Takeda coding conventions to ensure consistency and to optimize integration capabilities within and across therapeutic areas and programs.

  • Develops and maintains strong relationships with vendors who perform clinical trial coding, ensuring high-quality deliverables, consistent application of coding conventions, implementation, and oversight of metrics to ensure quality and productivity, appropriate resourcing, and process improvements as necessary.

  • Develops and maintains coding and dictionary management process for Takeda in collaboration with key stakeholders.

  • Reviews program and study-level clinical trials, serious adverse events (SAE), concomitant medications, and other relevant coded data performed by vendors for quality and consistency.

Educational Qualifications

MS/BS degree (RN or RPH preferred) in a health-related, life science area or technology-related fields.

Experience

  • 8+ year(s) of clinical data management coding experience in the pharmaceutical or biotechnology industry.

  • Minimum of 3 years of line management experience or equivalent.

  • Proven track record of strong project management skills and experience managing data management coding activities for large drug development programs.

  • Knowledge of GCP, regulatory and ICH guidelines as applicable to clinical data management; clinical experience in the one or more of the following therapeutic areas desired: cell therapy, oncology, GI, Neuroscience, PDT, Rare disease, and/or vaccine.

  • Proficiency in the structure, management, and application of MedDRA and WHO Drug dictionaries across the drug development spectrum (Phase I through post-marketing safety data management).

  • 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.

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

  • Working knowledge of one or more coding and clinical trial data management systems (Oracle Clinical, Oracle TMS, Medidata RAVE, InForm, etc.).

  • Experience overseeing vendors performing clinical trial medical coding.

  • Experience developing and maintaining coding processes and conventions.

Special Skills/Abilities

  • Familiarity with MedDRA, WHO Drug and other coding & reporting requirements.

  • Knowledge of MedDRA SMQ search strategies.

  • Demonstrated ability in strategic thinking, & risk assessment and mitigation.

  • Demonstrated ability in a matrix role management and communication with interdisciplinary teams.

  • Strong negotiation and conflict resolution and team building skills.

  • Excellent communication and interpersonal skills.

  • Proficiency with MS Office Suite (Work, Excel, Project, Visio) and report tools such as Elluminate, Spotfire or JReview.

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

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.

COMPENSATION

Base Salary Range: $143,500 to $205,000 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

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time