Associate Clinical Project Manager

Deciphera

  • Waltham, MA
  • Permanent
  • Full-time
  • 1 month ago
  • Apply easily
Company Summary:

Deciphera Pharmaceuticals is a commercial biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. In addition to advancing multiple product candidates in clinical studies, QINLOCK is Deciphera's first FDA-approved drug, a switch-control kinase inhibitor for the treatment of fourth-line gastrointestinal stromal tumor (GIST). QINLOCK, an oral oncolytic, is also approved in Canada and Australia for the treatment of fourth-line GIST.

Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered in Waltham, Massachusetts. Our state-of-the-art research facility is located in Lawrence, Kansas.

We offer an outstanding culture and opportunity for personal and professional growth based on our “PATHS” Core Values:

- Patients - places the importance of improving the lives of patients and their caregivers at the forefront of every day's work.

- Accountability - for our performance and the way we work with coworkers and other stakeholders.

- Transparency - in our intent and actions to both internal and external stakeholders.

- Honesty and Integrity - fosters trust and strives to deliver on our and the company's promises.

- Stewardship - values and uses wisely the resources and investments provided to the company.

Position Summary:

We are seeking an Associate Clinical Project Manager to support the management of clinical trials from initiation to completion while partnering with internal and external cross-functional disciplines.

This position will report to the Director or Associate Director, Clinical Operations and be located in the Waltham, MA office.

Key Responsibilities
  • Maintain study trackers and tools as directed by the CPM
  • Maintain study contacts list
  • Support site payments
  • Assist study team with preparation for audits/inspections
  • Assist in creating, editing, and distributing informed consent templates and other study documents
  • Support site start-up activities
  • Track 1572s and liase with Regulatory for IND submission as well as other essential documents as appropriate
  • Assist with Investigator Meeting Planning and may present at the meeting
  • Maintain study FAQ list
  • Assist with sample management
  • Perform quality control review of documents
  • Submit documents to the TMF
  • Perform TMF QC
  • Assist in Essential Document Packet (EDP) review and approval
  • Assist with resolution of vendor and investigational site data queries
  • Provides input and coordinates the delivery of clinical trial supplies
  • May perform SIVs
  • May provide study-specific training to vendors, CRAs and site staff
  • May manage 3rd party vendor as directed by the CPM
  • May participate in review of study core documents (protocol, IB, CSR)
  • May develop and maintain study documents
Required Qualifications
  • Bachelor's degree in health science or related field
  • A minimum of 3 years of relevant clinical operations experience in the pharmaceutical industry and/or CRO (oncology experience preferred)
  • Excellent verbal and written communications skills
  • Self-motivated, with strong organizational skills and attention to detail
  • Computer proficiency in MS Office (i.e. Word, Excel, PowerPoint, project)
  • Ability to travel approximately 20%

Deciphera