Senior Clinical Project Manager

Location
Burlingame, California
Salary
competitive
Posted
Jun 19, 2018
Required Education
Bachelors Degree
Position Type
Full time

Role and Responsibilities

  • Manage the operational aspects of clinical trials and proactively identify and address potential study issues/risks and recommend/implement solutions
  • Participate in CRO and vendor selection; develop RFPs for study vendors, review proposals and make CRO and vendor selection recommendations in collaboration with the Study team
  • Oversee contract organizations and external vendors to ensure that project goals are achieved; organize and lead teleconferences with vendors, facilitate vendor activities and oversee adherence to scope of work and budget
  • Manage and oversee internal and CRO monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols
  • Manage and report clinical operations project plan, including timeline, budget, resources and risks
  • Lead or participate in the design of study materials such as CRFs, CRF completion Guidelines, Subject Diaries, Monitoring plan, Laboratory Manual, Pharmacy Manual
  • Participate in protocol development, Informed Consent Form development, Clinical Study Report preparation, Data Review Committee activities as appropriate
  • Manage the review and approvals of Informed Consent Forms and other study related materials
  • Participate in the development, review and implementation of departmental SOPs and processes
  • Develop and implement innovative process ideas to optimize clinical trial conduct and management
  • Organize and manage internal team meetings, vendor meetings, investigator meetings and other trial-specific meetings
  • Oversee implementation and maintenance of study-specific Electronic Trial Master File
  • Assist with training vendors and team members on study protocol and processes
  • Manage clinical operations support staff as assigned (Clinical Trial Associates, Clinical Research Associates)  

  

Qualifications and Education Requirements

  • 5+ years of Clinical Operations or related experience required with experience in hematology/oncology indications
  • Bachelor’s degree required
  • Bachelor’s degree or higher in nursing, or health science preferred
  • Committed to the values of integrity, accountability, agility, and drive.
  • Local San Francisco Bay Area candidates only

 

Preferred Skills

  • Excellent teamwork and collaboration skills. Attention to detail required
  • Proficient with Microsoft Office.
  • Must have the ability to build and maintain positive relationships with management, peers, and direct reports
  • Flexibility and willingness to solve problems that fall outside of immediate area of expertise
  • Strong knowledge and experience of clinical operations, including interpretation and implementation of FDA regulations/ICH guidelines, is required
  • Previous line management experience preferred
  • Experience in oncology global trials preferred
  • Clear and concise verbal and written communication skills and strong organizational skills, with an exceptional attention to detail.
  • Work independently in an interdisciplinary, fast-paced, often changing environment.
  • Must be willing to travel