Director, Clinical Operations
Must be willing to be in-house in Boston (Prudential Center, Boylston Street, four days per week)
- Provide leadership and manage end-to-end processes involved in outsourced clinical trials, key deliverables are:
- Maintaining and remediation of operational efficiency at RT and designated CRO demonstrated by meeting development program goals per plan and within agreed upon budget
- Influencing, advising on, and analyzing study conduct issues and creating optimized and documented systems for study conduct at sponsor, CRO, and research site levels
- Direct site interaction managing site-specific subject identification, data entry oversight from a Clin Ops perspective, point of escalation for reimbursement issues
- Final responsibility for research site contract and budget negotiations
- Subject Matter Expert (SME)on ICH E6 rev 3
- Exercising consistent judgment and discretion within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for GCP-compliant and phase-appropriate study conduct
- Functional lead and responsible for GCP compliance and remediation in conjunction with the Head of QA
- Core member of infrastructure development team
- Clinical business lead for infrastructure evaluation and implementation
- Core NDA preparation team member
- Key planning role
- Reviewing and authoring assigned sections
- Coordinate timing and quality of deliverables from ESPs
Candidate Profile
- BS minimum degree requirement, MS or MA is preferred; an RN, BSN, FNP, PA experience is a plus
- Internally motivated to deliver high-quality work products on time and within budget
- Excellent communication and planning skills
- 10+ years of clinical trial operations experience and experience working in a smaller, fast paced environment highly preferred.
- Practical and broad experience with key elements of clinical trial management including streamlining operational activities of trial protocols and ensuring deliverables are attained in a timely manner
- Extensive experience with the identification, negotiation, management, and oversight of external vendor partnerships, such as CROs, for site activation and monitoring, data handling, medical writing, and safety reporting
- Experience building an internal clinical operations management function as well as hiring internal stakeholders to support trial needs and leveraging external consultants as needed
- Experience running and overseeing internationally conducted studies in rare-disease indications
- Experience with regulatory submissions, especially including INDs, annual reports for INDs, ODD, and FTD
- Able to prioritize multi-faceted role against dynamic timelines and rapidly changing corporate needs
- Advanced working knowledge of Microsoft Excel, PowerPoint, and Project
- Bonus: working experience using SmartSheets®, One-Pager Pro™, Medrio and Oracle clinical databases