Senior Clinical Operations Program Manager/Clinical Operations Program Manager - Early Clinical Operations
Location:
Cambridge , Massachusetts
Posted:
October 18, 2017
Reference:
1702178

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Sr. Clinical Operations Program Manager /Clinical Operations Program Manager in Early Clinical Operations in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Sr. Clinical Operations Program Manager / Clinical Operations Program Manager working in the Early Clinical Operations team, you will be empowered to oversee a robust portfolio of clinical programs and their clinical studies and collaborate with our strategic partners. A typical day will include:

OBJECTIVES:
  • 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.

ACCOUNTABILITIES:
  • 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


Qualifications:


EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:

Education:

  • Bachelors Degree or international equivalent required.
  • Life Sciences preferred.
  • Advanced degree is highly desirable.



Skills:
  • 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.

Physical demands include: manual dexterity required to operate office equipment (i.e. computers, phones, etc.).

TRAVEL REQUIREMENTS:

  • 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

No Phone Calls or Recruiters Please.



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A little about us:
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