Professional operations and management experience in Clinical Research working in CROs and Pharmaceutical companies in various functions: CRA, Team Leader, Site Partnership Manager, Vendor Manager, Start Up Lead.
Proven ability to optimize processes, enhance productivity, and drive team success. Strong focus on collaboration, adaptability, and achieving results. Skilled in strategic planning, resource management, and continuous improvement initiatives. Reliable and flexible, with commitment to meeting organizational goals.
Participation in BID and Client meetings. Development of partnership negotiation with clinical sites, Patient associations and third-party vendors. Close collaboration with Government team.
Full Clinical Trial Manager responsibilities that covers: Start Up activities (acting as Start Up Lead) and Project Management activities (Full Vendor Management responsibilities: budget, contract, set up, follow up); development of study tools and training materials; study systems set up; acting as a Single point of contact for Customers and Vendors.
Acting as Lead Clinical Trial Manager for study teams under partnership programs.
Participation in Bid and Investigators meetings.
Acting as Local Clinical Trial Manager with a support to Local Project Manager: Study tools development, training materials, mentoring of incoming CRAs, SME for systems and tools oversight, support with Vendors oversight, collaboration with Business and Research organizations and Patient Associations, etc.
Oversight of Partnership network with dedicated clinical sites. Collaboration with Patient Associations and National Government. Development of Partnership network with new hospitals, full oversight of all trials conducted at the Network sites: Feasibility to Close out. Preparation and participation in BID, where applicable.
Full Clinical Trail Lead responsibilities for dedicated Regions/Countries: development of study tools, training materials, resourcing of clinical team, reports review, primary point of contact for Customer from clinical perspective, support to PM with budget review, vendor oversight (where needed), etc.
Full CRA responsibilities: on-site and remote MVs, on-site and inhouse study oversight of assigned clinical sites, support to Regional/Global CTL, participation in the meetings with the Customers, where needed; involvement in the start up processes, where applicable (Contracting, systems set up, etc).
Therapeutic Areas/Indications: Oncology (Melanoma, Brest Cancer, Renal Cell Cancer, Gastric Cancer), Rare Disease (MOG, Duchenne Muscular Dystrophy), Cardiology ( Atrial Fibrillation), Rheumatology (Rheumatoid Arthritis), Respiratory (Bacterial Pneumonia)
Technical: MS Tools (Excel, Word, PP etc), Vault, Rave, InFormant, IRT/IVRS, etc