Reporting directly to the Clinical Operations Manager, the 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 Novadip Biosciences 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.

Your Responsibilities

• You proactively manage assigned clinical trial timeline, budget and milestone achievement and are accountable for ensuring that all project deliverables meet Novadip’s expectations and standards.
• You 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
• You are familiar with strict deadlines to meet project timelines, with the ability to modify work schedule when needed.
• You 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
• You serve as the primary key contact person for study CROs (DM, safety/pharmacovigilance, statistics…), you identify potential risks and resolve issues
• You 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.
• You oversee site monitoring visits and review monitoring reports, ensure clinical study Tracking and Reporting to all relevant parties
• You drive safety reporting and appropriate documentation for adverse event safety monitoring, towards the applicable health / regulatory authorities (US/EU)
• You manage study budget and accurate forecasts, while participating in requested approvals and contract negotiations
• You prepare for clinical audits and to respond to audit findings conducted by regulatory stakeholders.
• You proactively manage risks and contingencies and lead of innovative propositions to solve issues while escalating appropriately

Your Profile

• You have a Master in Life Science or equivalent Health degree, or a combination of education, training and experience
• You have at least 5 years experience of clinical project management at a sponsor or CRO company
• You have a relevant previous experience as Clinical Research Associate, or Site coordinator
• Previous experience in early phase and pivotal trials is a plus
• You are computer literate (MS Office suite, and clinical trial tracking systems)
• You are fluent in English (both spoken and written) and French. Any other language is an asset.
• You have strong project management skills (planning, scheduling, documentation, project control) and provide leadership to motivate, inspire and support the study team
• Your foster teamwork and have outstanding communication skills with multiple stakeholders.
• You are ready and able to be multitasking and have problem-solving abilities as you will work in a small team
• You have the willingness to maintain our company values (People, Innovation, Passion, Excellence), while demanding the highest standards of conduct from self and others.

Our offer

• A diversified full-time permanent position within a high-potential innovative biotech company.
• To work in a human-sized, dynamic, respectful and professional environment.
• The opportunity to take part in a challenging scientific and business growth.
• An attractive salary package in line with the position responsibilities and your experience.