Description Aktis Oncology is seeking a Clinical Trial Manager/Senior Clinical Trial Manager.
This role will report to the Senior Director of Clinical Operations.
ResponsibilitiesThis role will drive several areas of strategic importance to Aktis:
- Leads and responsible for overall clinical trial management from start-up to database lock for assigned clinical studies.
- Reviews and authors applicable sections of clinical protocols, CRFs, study reports, IB, informed consent forms and study plans/manuals; implements and monitors progress against project timelines
- Proactively identifies project risks and develops resolution plans
- Participates in the selection of Investigators and vendors
- Chairs and leads multi-disciplinary internal and external study team meetings
- Maintain close communications with internal staff and oversight of CROs and clinical sites to ensure assigned projects meet timeline, budget, and quality goals.
- 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. 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
- Broad understanding of operations including those in related development functions
- Demonstrates ability to effectively interface with key medical personnel at clinical site(s)
- Demonstrates ability to flag processes that may not be appropriate for study based on phase, design, and/or use of data
- Maintains a flexible, proactive approach to plan for and address issues
- Possesses excellent written and oral communication skills
- Train/mentor junior staff
Qualifications- B.S. degree or equivalent, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
- Minimum of 3-5 years (or 5+ if Senior) of clinical trial management experience in the pharmaceutical, biotech and/or CRO industry
- Oncology therapeutic area experience is required for this position.
- Radiopharmaceutical experience is a preferred
- Strong 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
- Willingness to travel up to 10-20% of time (eg site visits, conferences, etc)
- Strong desire to be part of a patient-centric company.
- Proven demonstration of transparent communication and fostering open and diverse debate.
- Ability to work with agility and manage ambiguity.
