Clinical Project Manager

工作内容

This position is open for candidates with a min of 5 years experience in Clinical Project Management and previous experience as a CRA.
Hybrid working opportunity at client’s location (Walloon Brabant) : 3 days/week on site + 2 days/week homebased.

Job Description

Reporting directly to the Clinical Operations Manager, the Clinical Project Manager (CPM) will lead, coordinate and manage all aspects of clinical study activities to ensure compliance with regulatory requirements, timelines and goals within budget and quality requirements towards the registration of our client’s products.
These tasks will be performed in compliance with current regulations in the field, including SOP’s, ICH and Good Clinical Practice (GCP) guidelines, and all other laws and directives EU/US on clinical activities. The Clinical Project Manager works in partnership with operational and strategical stakeholders to proactively identify and evaluate fundamental study-related issues on the project, set-up strategies to handle these effectively or ensure the implementation of timely solutions.

Responsibilities

• Proactively manage assigned clinical trial timeline, budget and milestone achievement and are accountable for ensuring that all project deliverables meet the company’s expectations and standards.
• Coordinate and manage all operational aspects of clinical trial activities from study start-up (ie. conduct of the Trial Kick-off meeting, site selection and supporting CROs selection) to close-out activities
• Familiar with strict deadlines to meet project timelines, with the ability to modify work schedule when needed.
• Coordinate & provide clinical input and/or develop study-related materials such as:
• Provide input/write/review clinical study documents and Plans (ie. Protocols, Clinical Monitoring Plan and all ad- hoc requested forms)
• Coordinate and perform site selection and IRB/EC submissions up to site initiation and activation
• Serve as the primary key contact person for study CROs (DM, safety/pharmacovigilance, statistics…), you identify potential risks and resolve issues
• Communicate and work closely with study site staff and investigators to ensure/facilitate robust local plans, to achieve fast start-up of sites and cost-effective delivery of target.
• Oversee site monitoring visits and review monitoring reports, ensure clinical study Tracking and Reporting to all relevant parties
• Drive safety reporting and appropriate documentation for adverse event safety monitoring, towards the applicable health / regulatory authorities (US/EU)
• Manage study budget and accurate forecasts, while participating in requested approvals and contract negotiations
• Prepare for clinical audits and to respond to audit findings conducted by regulatory stakeholders.
• Proactively manage risks and contingencies and lead of innovative propositions to solve issues while escalating appropriately

Requirements

• Master in Life Science or equivalent Health degree, or a combination of education, training and experience
• At least 5 years’ experience of clinical project management at a sponsor or CRO company
• Relevant previous experience as Clinical Research Associate, or Site coordinator
• Previous experience in early phase and pivotal trials is a plus
• Fluent in English (both spoken and written) and ideally French (valuable asset)
• Computer literate (MS Office suite, and clinical trial tracking systems)
• Strong project management skills (planning, scheduling, documentation, project control) and provide leadership to motivate, inspire and support the study team
• Foster teamwork and have outstanding communication skills with multiple stakeholders.
• Ready and able to be multitasking and have problem-solving abilities as you will work in a small team
• Willingness to maintain our company values (People, Innovation, Passion, Excellence), while demanding the highest standards of conduct from self and others.
• Existing right to work in Europe required

Benefits/Contract information

• A balanced salary package based on your capabilities and experience
• Start-date : ASAP
• Schedule : full-time or 80%
• Hybrid working : 3 days/week on-site + 2 days/week remote

Vacancy number : 23998