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.
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.
- 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
- 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%