B.S. degree in Life Sciences (Biology, Chemistry, etc.)
3-5 years clinical trial management experience (5+ for Senior role)
Oncology therapeutic area expertise required
Preferred experience in radiopharmaceuticals
Strong knowledge of ICH Good Clinical Practice guidelines
Proficient in managing global/regional teams in virtual environments
Proven record of managing trials from start to database lock
Responsibilities
Lead overall clinical trial management from start-up to database lock
Review and author clinical protocols and study documents
Proactively identify project risks and develop resolution plans
Select Investigators and vendors for trials
Chair multi-disciplinary internal and external study team meetings
Ensure timeline, budget, and quality goal compliance
Manage study budgets and review vendor invoices
Benefits
Collaborative work environment
Opportunity for professional growth and development
Access to innovative clinical research projects
Flexibility in managing work and travel arrangements
Potential for mentorship opportunities
Full Job Description
Description
Aktis Oncology is seeking a Senior Clinical Trial Manager.
This role will report to the Senior Director of Clinical Operations.
Responsibilities
This 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.
