Clinical Bioanalytical Sample and Project Manager
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Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Clinical Bioanalytical Sample and Project Manager in our Cambridge, MA office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
OBJECTIVES:
- Contribute to the success of a clinical bioanalytical study function responsible for various serology testing and assigned to the Dengue clinical development program within the Vaccines Business Unit (VBU). Activities will include, managing and overseeing clinical sample handling and disposition with contracted testing laboratories, central labs, and long-term storage vendors.
- Responsible for facilitating sample reconciliation with outside vendors and leading sample , document , and critical reagents management within the clinical bioanalysis team, in compliance with Takeda processes and international regulatory and quality standards.
- Ensures quality compliance of bioanalysis team and associated governance structures.
ACCOUNTABILITIES:
- Responsible for sample management for clinical studies including logistics, data transfer agreements, long term storage and overall sample management
- Support clinical assay team with regard to GCP principles to align with trial objectives
- Responsible for reviewing clinical trial lab manuals, preparing Serology Plans, following clinical samples through delivery to bio-analytical vendor, testing, data transfer and long-term storage.
- Support and lead clinical serology documentation needs in a GCP compliant manner
- Coordinate the drafting and execution of contracts and Work Orders with bio-analytical vendor labs, based on Serology Plans.
- Lead sample management for the clinical study beginning with oversight of shipment conditions and timing from the clinical site to the central laboratory, delivery of samples to the bio-analytical vendor, testing, reconciliation, data transfer, and final long-term storage or further use approval of clinical samples. Familiar with LIMS.
- Oversee the review of the Lab Manual, provided by the contracted central lab vendors, to guarantee proper sample management. Partner with Clinical Delivery project manager to implement the Serology Plan for the clinical endpoints in studies, in compliance with GCP-ICH guidelines.
- Inform Quality Assurance team on any quality deviation of sample management and clinical sample testing. Actively collect, investigate, review and document the above quality deviations for clinical sample handling or testing in the appropriate QA system.
- Lead development of inventory and management of clinical critical reagents required for bioanalytical method performance.
- Oversee the trial master file (TMF) documents owned by VBD in accordance with regulatory requirements and the Takeda Quality management system.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
Education & Experience
- Advanced degree (Masters) with a minimum of 3 years demonstrated excellence in and clinical biosample management experience. Preference given for work in the pharmaceutical industry and/or within clinical development.
- Alternatively, bachelor’s degree or international equivalent in the life sciences with a minimum of 7 years practical laboratory experience.
- Working understanding of GMP, GLP, GCP-ICH and/or GCLP guidelines. Knowledge of product development processes, preferably in biologics and/or vaccines.
- Successful experience in working with globally operating matrix teams and in the coordination of various internal and external interfaces (academia, in-house labs, and contracted vendors).
- Proven leadership, team building skills and strategic problem-solving ability. Demonstrated ability to manage and lead others through change. Demonstrated ability at managing matrix teams, influencing outcomes and key project decisions.
- Proven ability to communicate and collaborate effectively with senior management. Experience interacting with external collaborators with ability to build strong relationships.
- Knowledge of risk management, project reporting, and project management tools.
- Strong interpersonal skills particularly motivational, negotiation, listening, judgment, analytic, and conflict management skills, demonstrated by ability to lead highly technical teams.
- Excellent organization, verbal and written communication skills to explain project goals and inspire support.
- Ability to work well with cross-functional teams to accomplish objectives. Ability to work effectively in a fast paced, rapidly changing technology environment, and to work on multiple work streams and projects simultaneously.
- Demonstrated time-management organizational skills.
- Fluent spoken and written English.
LICENSES/CERTIFICATIONS:
- PMP preferred
This position is currently classified as “onsite” in accordance with Takeda’s Hybrid and Remote Work policy.
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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:
Boston, MAU.S. Base Salary Range:
$108,500.00 - $170,500.00The 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.
U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
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.
