Sr Clinical Project Manager

Job title: Senior Clinical Project Manager (remote)
Type: Direct-Hire/ Permemant
Location: Remote
Salary: $165,000-$175,000, plus 17.5 annual performance bonus
Start date: Immediately ! Job Description
Responsibilities:
- Represents and leads the study team to design, develop and deliver the study to agreed upon timelines
- Leads the planning and communication with cross functional teams to ensure proper execution and conduct of the clinical trials
- Provides oversight and management of CROs and vendors
- Oversees and monitors the management of clinical studies ensuring they are conducted in compliance with agreed upon study plans through regular CRO and/or investigator site contact
- Monitors progress of clinical activity and reports on progress of assigned clinical trials including budget and timelines
- Monitors status of clinical data collection of assigned clinical trials
- Prepares potential investigator site lists and assists with their evaluation for inclusion in the study
- Develops study-related documents
- Reviews and approves study-related plans generated by CROs, vendors and ensures the documentation are in accordance with GCP, regulatory requirements and consistent with the protocol
- Assist study team with preparation for audits/inspections
- Participates in the review and finalization of clinical study-related documents such as protocols, protocol amendments, and CSRs
- Prepare and deliver program/study updates
- Manages escalation of study related issues and communicates as appropriate to management
- Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight
- Present on-going study updates to Clinical Leadership
- Contributes to development of RFPs and participate in selection of CROs/vendors
- Evaluates issues found in clinical studies, communication and oversight of CROs and vendors, and suggests and implements solutions and mitigations as required
- Provides oversight for the setup, maintenance, and close out of the Trial Master File and ensures 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
- Demonstrates excitement around the Vison and Mission of Deciphera and the department
- Other duties as assigned
Re quirements:
- A candidate who has had CPM for at least 3 years min; must be able to LEAD a study independently
- Strong Ph II and III
- ust have CRO/vendor mngt
- Must have full lifecycle experience as a PM (study start-up, through closeout/database lock)
- Oncology preferred, but not required...global preferred
- Proactive; solution-oriented, motivated, bright energetic hard-working, team player
- 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
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.