An experienced Clinical Trial Manager is needed to manage the cross-functional Study Team for a multinational pharmaceutical company.
Bachelors’ Degree in Science / Pharmaceutical / Healthcare or equivalent
6 10 Years Clinical / Drug Development experience
Working knowledge of regulatory standards and GCP guidelines
Highly experienced in managing early development phase clinical studies
Good management skills and experience in leading a team
Experience in planning, risk mitigation strategies, trial budgets, site selection, clinical supplies management, sample management, conduct and monitoring of clinical studies
Ability to support projects and initiatives
Excellent planning and organizational skills
Independently lead cross-functional Study Team within Clinical Operations with minimal oversight from the CPL
Accountable for Clinical Operations deliverables to achieve study objectives and milestones within timelines and budgets
Responsible for vendor selection and management including CRO, IVRS, central lab, imaging vendor
Provide input to the program budget and is accountable for managing overall study budget
Identify and track timelines, milestones, critical study activities, issues and budget and provide regular updates to the Study Team and CPL as appropriate
Partner with CPL to develop and present at project teams and management review bodies
Ensure relevant functional groups provide input to and participate in developing and finalizing Study Team level documents and meet Study Team level deliverables within timelines
Conduct protocol and site feasibility assessments
Provide drug supply assumptions to clinical planning team
Delegate and oversee study activities assigned
Managing and supporting Clinical Operations staff
Should you meet the requirements for this position, please email your CV to pharmacy.jobs hireresolve.co.za or fax to 086 571 7307 or alternatively call on 021 551 8638.
Correspondence will only be conducted with short listed candidates. Should you not hear from us within 3 days, please consider your application unsuccessful.