Senior Clinical Operations Program Manager/Clinical Operations Program Manager - Early Clinical Operations - United States
- You will provide operational expertise and strategic input to the development of Early Clinical Research Plans (ECRPs).
- You will develop and lead the operational strategy on assigned programs in close collaboration with our strategic partner.
- You will represent Clinical Operations on both the Global Program Team (GPT) and the Clinical Sub Team (CST).
- You will provide sponsor’s oversight of our strategic partner, program-level direction and support to the clinical study manager(s) responsible for the execution of your studies.
- Translate the Early Clinical Research Plan into an optimal operational plan
- Plan and oversee the overall execution of the assigned early clinical program(s) to meet necessary quality, budget and timelines,
- Responsible for program budget planning and accountable for external spend related to program execution.
- Communicate program status, cost and issues to ensure timely decision-making by senior management
- Responsible for operational risk management strategy in collaboration with Strategic Partners
- Review and provide expert clinical operations input into clinical documents such as Investigator Brochures, Investigational New Drug Applications (INDs) and/or Investigational Medicinal Product Dossier (IMPDs), study synopsis protocols, clinical study reports
- Ensure adequate clinical operations resources are assigned to programs
- Support functional strategic initiatives and process improvement
- Act as a role model for Takeda´s values
EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:
Education: Bachelors Degree or international equivalent required, Life Sciences preferred. Advanced degree is highly desirable.
- Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required.
- Demonstrated excellence in project/program management and matrix leadership
- Excellent teamwork, organizational, interpersonal, and problem solving skills
- Fluent business English (oral and written)
Experience: 8+ years experience in pharmaceutical industry and/or clinical research organization, including 5+ years clinical study management. Experience should include early phase studies and global/international studies or programs. Experience in more than one therapeutic area is required.
- Requires approximately 10-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel.
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Empowering Our People to Shine
Learn more at takedajobs.com.
Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx
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