- Work closely with Clinical Operations and Development Team in generating and overseeing study plan(s)
- Leads and manages internal and external clinical operation activities for complex clinical study(ies). Oversees daily activities and deliverable of CRO
- Contributes significantly to relevant study documentation including project plans; implements and monitors progress against project plans and revises as necessary
- Reviews and authors applicable sections of clinical protocols, CRFs, study reports, IB and informed consent forms
- Proactively identifies project risks and develops resolution plans
- Participates in the selection of Investigators and vendors
- Participates in study data review and assists with site management to ensure data quality/timely data entry
- Responsible for managing approved study budget(s) against trial progress and bring deviations to department leads. Review and approve Vendor invoices, including investigator grants and pass through costs.
- Assists with the negotiation & establishment of contracts and budgets with external clinical sites and vendors
- Collaborate with CMC and clinical supply colleagues to properly project for drug supply needs
- Track record of strong study management showing clear proficiency in clinical project management skills
- Solid vendor management skills
- Broad understanding of operations including those in related development functions
- Demonstrates detailed understanding of clinical protocol, intended study populations as well as solid overall drug development
- Demonstrates ability to effectively interface with key medical personnel at clinical site(s)
- Demonstrates ability to lead multi-disciplinary teams
- Demonstrates ability to flag processes that may not be appropriate for study based on phase, design, and/or use of data
- Maintains a flexible, can-do approach to address issues proactively and innovatively
- Possesses excellent written and oral communication skills
- B.S. degree or equivalent, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
- Minimum of 3-5 years for a CTM and 5-8 years for a Senior CTM of clinical trial management experience in the pharmaceutical, biotech and/or CRO industry
- Oncology therapeutic area experience is required for this position. Phase 1 and/or 2 experience preferable
- Working knowledge of ICH Good Clinical Practice guidelines
- Requires clinical research operational knowledge, computer literacy, and strong project planning/management including oversight of CROs/vendors
- Experience and ability to manage global or regional teams in a virtual environment
- Proven track record in successfully managing trials from start-up to database lock
- Strong decision-making and communication/collaboration skills are essential to this position, as are analytic skills and effectiveness in seeking solutions to issues
- Must be adaptable and enjoy working in a fast-paced environment
- Effective leadership skills and proven ability to foster team productivity, cohesiveness, and quality deliverables
- Willingness to travel up to 10-20% of time
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Meet Boston, United StatesAre you an experienced Clinical Operations professional looking to advance your career in a dynamic and innovative environment? Do you thrive in a fast-paced setting and excel at managing clinical trials from start to finish? If so, we have an exciting opportunity for you to join ...
Senior Clinical Trial Manager/Clinical Trial Manager - Boston, United States - Fusion Pharmaceuticals LLC
Description
Fusion Pharmaceuticals (NASDAQ: FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusions clinical portfolio includes: FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; and FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial. In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel targeted alpha therapies (TATs) and combination programs between Fusions TATs and AstraZenecas DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Mercks KEYTRUDA (pembrolizumab) in patients with solid tumors expressing IGF-1R. To support Fusions growing pipeline of TATs, the company has signed strategic actinium supply agreements with TRIUMF, Niowave, and BWXT Medical.
Responsibilities:
Qualifications
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual, gender identity, national origin, disability, or status as a protected veteran.
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