Senior Manager, Clinical Data Management

Takeda Pharmaceutical Co.; Agawam (MA); Hybrid; USD 137,000 - 215,000; Full time

Job summary

Takeda Pharmaceutical Co. is seeking a Senior Manager, Clinical Data Management to lead a medium-sized team of managers, supervisors, professionals and specialists, guiding daily operations as needed.

You will provide strategic direction, training, and decisions aligned with business plans while overseeing projects, budgets, schedules and performance standards, and engaging internal and external stakeholders at multiple management levels.

Qualifications

• Bachelor’s degree with 6+ years, or Master’s degree with 3+ years of relevant industry experience in CRO or Pharmaceutical or related field.
• Capable of leading complex clinical trials independently and mentoring others.
• Proficient in using Electronic Data Capture systems in highly complex situations and advising improvements.
• Experienced in data validation and improving validation processes and coaching others.

Responsibilities

• Oversee and manage a team of clinical data management professionals
• Ensure clinical trials are conducted in compliance with regulatory standards
• Develop and implement process improvement strategies for clinical data management
• Provide strategic guidance and act as an advisor and trainer to the team
• Manage projects, budgets, schedules, and performance standards
• Engage with internal and external stakeholders at various management levels
• Present findings and updates at meetings

Skills

Team leadership

Regulatory compliance

Process improvement

Strategic guidance

Budget management

Stakeholder management

Presentations

Education

Bachelor's degree

Master's degree

Tools

Electronic Data Capture (EDC) systems

Job description

Job Description

Join Takeda as a Senior Manager, Clinical Data Management, you oversee a medium-sized team of managers, supervisors, professionals, and specialists working on diverse topics. While actively involved in daily operations when necessary. You will also provide strategic guidance, act as an advisor and trainer to your team, and make decisions guided by the sub-function business plans. Your responsibilities include managing projects, budgets, schedules, and performance standards, as well as engaging with internal and external stakeholders at various management levels and presenting findings at meetings.

About the role:

The Senior Manager Clinical Data Management is responsible for overseeing a team of professionals in the development, evaluation, and testing of clinical data management processes. This role ensures that clinical trials are conducted efficiently and in compliance with regulatory standards, contributing to Takeda's mission of bringing better health to people and a brighter future to the world.

How you will contribute:

• Oversee and manage a team of clinical data management professionals


• Ensure clinical trials are conducted in compliance with regulatory standards


• Develop and implement process improvement strategies for clinical data management


• Provide strategic guidance and act as an advisor and trainer to the team


• Manage projects, budgets, schedules, and performance standards


• Engage with internal and external stakeholders at various management levels


• Present findings and updates at meetings

What you bring to Takeda:

• Preferred bachelor’s degree with 6+ years, or master’s degree with 3+ years of relevant industry experience in CRO or Pharmaceutical or a related discipline.


• Fully capable of performing complex clinical trials independently, providing recommendations for improvements and coaching others.


• Proficient in using Electronic Data Capture systems in highly complex situations, capable of advising others and recommending improvements.


• Performs advanced data validation tasks independently, capable of improving validation processes and mentoring others in basic techniques.


• Advanced in auditing, capable of handling highly complex situations, making improvement recommendations, and coaching others.


• Advanced understanding and application of Good Clinical Practices, capable of leading clinical trials and mentoring others on compliance and ethical considerations.


• Fully capable of performing and improving clinical data management processes, can apply knowledge in highly complex situations and guide others.


• Fully independent in clinical research, capable of guiding others and making improvement recommendations in complex situations.


• Excellently manages tasks requiring high attention to detail, independently addresses complex scenarios, and advises others on maintaining precision.


• Fully independent in data cleansing, capable of handling highly complex situations and making improvement recommendations, can coach others.


• Capable to independently managing and improving organizational structures and processes, can coach others in effective organization.

Important Considerations:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.


• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.


• Work in a cold, wet environment.


• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.


• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

#GMSGQ #ZR1 #LI-MA1

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Massachusetts - Virtual

U.S. Base Salary Range:

$137,000.00 - $215,270.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

For information about our benefits, please click here.

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

Job Exempt Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

#LI-Remote