What are the responsibilities and job description for the Senior Clinical Trial Manager position at Fusion Pharmaceuticals?

Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion’s 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; FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial; and FPI-2068, a bispecific IgG-based EGFR-cMET targeted radioconjugate currently in a Phase 1 trial. In addition, Fusion is pursuing combination programs between RCs and DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. Fusion has a fully operational Good Manufacturing Practice (GMP) compliant state-of-the-art radiopharmaceutical manufacturing facility to meet supply demand for Fusion's growing pipeline of RCs.

As a member of the Clinical Operations team, you will collaborate closely with cross functional teams including clinical development, safety, data management, bio analytics, manufacturing, supply chain, regulatory, medical affairs, and quality ensuring successful delivery of assigned trials.

If your skills, experience, and qualifications match those in this job overview, do not delay your application.

Responsibilities :

Partner closely with Clinical Operations and Clinical Development colleagues in generating and overseeing study plan(s)
Working with and overseeing Contract Research Organizations (CROs) and other external vendors.
Demonstrated ability to drive end to end clinical trial activities : i.e. experience in all aspects of study start-up and oversight of study execution, database lock, and close out.
Leads and manages internal and external clinical operation activities for complex clinical study(ies). Oversees daily activities and deliverable of CRO
Participates in all CRO study related calls and meetings, tracks actions, escalates issues and oversees all aspects of daily study operations.
Lead and co-lead internal study operational calls and meetings
Report on all aspects of the study progress at a granular level to Operations management. Effective, consistent & regular tracking of project (s).
Collaborates in the preparation and / or review of study-related documents (e.g., Study Operations Plan, Monitoring Plan, Pharmacy Manual, Informed Consent, Laboratory Manual, CRF Completion Guidelines, study tools / worksheets and other study-specific documents or manuals).
Ensures audit-ready condition of clinical trial documentation including central clinical files.
Contributes significantly to relevant study documentation including project plans; implements and monitors progress against project plans and revises as necessary
Collaborates in the writing and review of study protocols, CRFs, study reports, IB and informed consent forms
Ability to proactively identify issues and risks, develops and manage mitigations and / or escalate risks appropriately.
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
Ensures the assigned clinical trials executed in compliance with FDA and ICH / GCP guidelines / regulations and SOPs.
Ensure Trial Master Files (eTMFs) are properly maintained.
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
Collaborate with cross-functional AstraZeneca team members on specific programs
Work under AstraZeneca SOLIS Model on designated studies
Maintains a flexible, can-do approach to address issues proactively and innovatively
Possesses excellent written and oral communication skills

Qualifications

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 managing global clinical trials in the pharmaceutical, biotech and / or CRO industry.

Oncology therapeutic area experience is required for this position. Phase 1 and / or 2 experience preferable.

Radiopharmaceutical experience is a plus.

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

Inspection readiness mindset with a focus on quality for all trial-related activities

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

Solutions driven with strong decision-making and communication / collaboration skills are essential to this position, as are analytic skills.

Critical thinking skills for problem solving and have the lateral and strategic thinking capacity to drive the study(ies) and understand the upstream, downstream and lateral implications of decisions that affect study outcomes and timelines.

Comfortable multi-tasking in a fast-paced small company start-up environment and able to adjust workload based upon changing priorities. Adaptable / flexible, self-starter (willing and able to adjust to multiple demands, sometimes beyond job descriptions and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)

Strong self-starter with willingness and ability to fill functional gaps in a small organization.

Excellent team player but also independently without significant oversight.

Effective leadership skills and proven ability to foster team productivity, cohesiveness, and quality deliverables.

Willingness to travel up to 10-20% of time

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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