Under the direction of a Project Manager Lead supports overall project management of clinical studies by helping control the scope, schedule and cost of assigned project(s), which may range from single service studies to full scope or multiple protocol projects.
Duties may include liaising with Customers, vendors and / or investigative sites to manage projects from proposal development to final deliverables to the customer.
Upon displaying proficiency, a Project Manager (PM I) may be awarded the opportunity to function at the Project Manager II (PM II) level within a large project team or on a small project which offers continued mentorship.
Creates and maintains the Trial Master File Management (TMF) Plan. Routinely reviews the TMF to ensure quality, completeness and inspection readiness
Coordinates and monitors the activities associated with study deliverables across all applicable internal functional departments and vendors.
Assists with activities associated with interim analyses, database snapshots and locks, final CSR and study closure
Assists with identification of and contracting with approved vendors, as necessary
Provides vendor management, inclusive of ensuring key deliverables are met, potential scope creep is identified and change orders are developed, as necessary
Assists with development and implementation of change orders
Assists with resource management and team member transition by collaborating with appropriate Resource Managers and ensuring detailed Transition Plans are developed and implemented efficiently
Financials / Reporting
Develops contingency planning and risk mitigation strategies to ensure meeting or exceeding study milestones.
Creation and maintenance of metric reports, inclusive of data collection from multiple sources, for delivery to client or senior management
Assists with overall financial performance of the study by interacting with internal functional departments or vendors to obtain required metrics for financial reporting
Attends financial review meetings to assist with reconciliation and identification of budget overrun
Reviews and approves invoices from sites or vendors and to the client
Participates in representing the company to the client, ensuring satisfaction levels are met and statuses of deliverables are communicated effectively.
May participate in Customer proposal development
In collaboration with the Project Team, will plan, coordinate and present at internal and external meetings
Knowledge / Training
Facilitates team training in accordance with protocol and / or project requirements, including therapeutic, protocol specific, and process training
Develops knowledge of current therapeutic environment
QUALIFICATION REQUIREMENTS (please indicate if preferred’)
Bachelor’s Degree (or equivalent) level of qualification in Life Sciences, Medicine, Pharmacy, Nursing or related field equivalent preferred
Prior experience in a contract research organization (CRO), pharmaceutical, or biotechnology company preferred. CRO and relevant therapeutic experience preferred
Strong knowledge of Good Clinical Practice / ICH guidelines and other applicable regulatory requirements
Strong organizational skills
Strong ability to manage time and work independently
Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince and persuade
Flexibility and ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment
High level of competency in English language
Proficiency with MS Office Applications
Ability to travel as necessary (up to 25%)
Latin America - ARG-BuenosAires-Avda-del-Liber
Latin America - BRA-RiodeJaneiro-Rua-da-Passag, Latin America - CHL-Santiago-AvNuevaProvidenc
Clinical Project Management