Senior Clinical Project Manager

2 weeks ago

Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full time
Job Title: Senior Clinical Project Manager

Deciphera Pharmaceuticals is seeking a highly skilled Senior Clinical Project Manager to lead the successful execution of clinical trials from protocol conception through the clinical study report. The ideal candidate will have a strong background in clinical trial management, excellent communication and organizational skills, and the ability to work effectively in a cross-functional team environment.

Key Responsibilities:
  • Design, develop, and deliver clinical trials to agreed-upon timelines
  • Lead planning and communication with cross-functional teams to ensure proper execution and conduct of clinical trials
  • Provide oversight and management of CROs and vendors
  • Monitor progress of clinical activity and report on progress of assigned clinical trials, including budget and timelines
  • Monitor status of clinical data collection of assigned clinical trials
  • Prepare potential investigator site lists and assist with their evaluation for inclusion in the study
  • Develop study-related documents
  • Review and approve study-related plans generated by CROs, vendors, and ensure documentation is in accordance with GCP, regulatory requirements, and consistent with the protocol
  • Assist study team with preparation for audits/inspections
  • Participate in review and finalization of clinical study-related documents, such as protocols, protocol amendments, and CSRs
  • Prepare and deliver program/study updates
  • Manage escalation of study-related issues and communicate as appropriate to management
  • Ability to anticipate potential study issues and prepare contingency plans with minimal oversight
  • Present ongoing study updates to Clinical Leadership
  • Contribute to development of RFPs and participate in selection of CROs/vendors
  • Evaluate issues found in clinical studies, communication, and oversight of CROs and vendors, and suggest and implement solutions and mitigations as required
  • Provide oversight for the setup, maintenance, and close-out of the Trial Master File and ensure it is complete and inspection-ready
  • Responsible for assuring compliance with internal SOPs, FDA regulations, and GCP
  • Provide input as the subject matter expert for assigned studies during regulatory inspections
  • Mentor other clinical operation team members and may have direct reports
  • May simultaneously lead/manage more than one clinical trial
  • Demonstrate excitement around the Vision and Mission of Deciphera and the department
  • Other duties as assigned
Qualifications:
  • Bachelor's degree in health science or related field
  • Minimum of 5 years in clinical trial management
  • Excellent communication (oral and written), organizational, and problem-solving skills
  • Working knowledge of ICH guidelines, GCP, and current global regulatory requirements and guidelines for clinical trials
  • Strong experience facilitating project team meetings, cross-functional team communication, and decision-making, and ensuring alignment with stakeholders
What We Offer:
  • Comprehensive benefits package, including non-accrual paid time off, summer vacation bonus, global company-wide summer and winter shutdowns, annual lifestyle allowance, monthly cell phone stipend, internal rewards and recognition program, medical, dental, and vision insurance, 401(k) retirement plan with company match, life and supplemental life insurance for family, short and long-term disability insurance, health savings account with company contribution, flexible spending account for either health care and/or dependent care, family planning benefit, and generous parental leave

Deciphera Pharmaceuticals is an equal employment opportunity employer and values diversity. We invite you to voluntarily provide demographic information in a confidential survey at the end of this application. Providing this information is optional and will not affect your opportunity for employment. Our commitment to increasing diversity in our candidate pool does not affect our commitment to equal employment opportunity, including our ongoing commitment to make all hiring and other employment decisions solely on a nondiscriminatory basis.

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