Clinical Project Manager

Interested ? Don’t hesitate to take a look at the job description below !

julie.licoppe@professionals.randstad.be

• 
  Minimum of BA/BS in a biomedical discipline or equivalent education / training is required
• At least 5 years relevant experience in clinical research and drug development with clinical operations experience. Preferably with first experience in early drug development (phase I and IIa)
• Substantial clinical operations and pharmaceutical industry experience in order to have a thorough understanding of the processes associated with executing clinical development plans and addressing related regulatory issues
• Experience in project management and leadership of matrix teams is essential
• Fluent in speaking and reading English, preferably, your second language would be French or Dutch
• Drug development experience including familiarity with: clinical study management and monitoring, project / process management, data management, clinical and regulatory processes, regulatory submissions, budget / expense management, experience of vendor management, scientific excellence, administrative excellence, systems technology
• Initiating and implementing change: innovation, learning, organisation, flexibility and resilience, courage with decisiveness to act, problem solving, positive approach, forward thinking, challenge the status quo
• Matrix leadership skills: influencing, collaborative, supportive, networking and alliance building, personal leadership, team work, communication, negotiation, decisive and assertive, change agile, able to deal with ambiguity
• Ease using office tools suite (excel, powerpoint, word, outlook, etc)

Consulting project

We offer an attractive salary with extra-legal advantages:

• Group insurance
• Hospitalisation insurance
• Meal vouchers of 7 euros gross per working day
• Reimbursement km or company car
• Monthly allowance (50 euros net per month)
• A 13th month
• Training
• Etc

A rate as freelance is also possible

Our client contributes to improving the health and well-being of people at every stage of their lives. They have built a strong product portfolio that enables prevention as well as treatment and cure for diseases in a wide range of therapeutic areas.

• 
  Initiates and manages all operational study / project activities & serves as primary point of contact for the assigned core project teams
• Translates protocol / project strategies from a concept into an executable study / project
• Focuses upon the operational integrity and feasibility of individual studies utilising a variety of resource solutions to ensure the most effective, efficient, and high quality study / project is designed and executed
• Participates in and influences the operational strategy for study / project delivery including milestone deliverable to optimise use of time, cost and resources
• Participates in the identification, assessment and mitigation of risks at the study level
• Maintains continuous communication between partner lines, strategic partners, clinical research unit, contractors and vendors
• Optimise operational control and effectiveness
• Assures close partnership with study investigators to assure successful study delivery and high quality data
• Fosters positive community attitudes and volunteer trust through professional behaviour and ongoing communication
• Responsible for assigned study / project management within the unit including study scheduling, protocol planning (start up activity) and will be the primary contact for the project teams responsible for the compound / project - from the time the study / project document is drafted until the data base / project is locked
• Serves as primary liaison / point of contact for the assigned core project teams and the clinical research unit
• Create and ensure adherence to study timelines
• Supervises initiation and monitoring of all study activities
• Primary point of contact for assigned study decisions related to the protocol, data collection and volunteer activities
• Partners with different departments for the planning and execution of study
• Maintains accuracy, accessibility and confidentiality of all volunteer records and reports
• Monitors and summarises clinical data
• Evaluates and may identify new equipment / technologies / vendors for improving study execution
• Lead the data management activities for assigned protocols
• Initiate inform consent document for ethics committee submission
• Responsible for ensuring clinical trials are conducted in accordance with scientific, medical, and ethical principles, and within regulatory requirements/guidelines. Responsible for volunteer safety and accurate interpretation and execution of research protocols including multiple study activities
• Contributes to the clinical study components with respect to time, operation feasibility, and study-level resources required to deliver individuals studies against the development plan (part of the study budget)
• Assesses impact of technologies required to deliver clinical trials and incorporates the development of these technologies into the clinical studies to ensure qualitative conduct and data collection suitable for purpose
• Provides support for methodology / mechanistical studies as appropriate
• Partners with core project teams to provide study schedule and budget information to enable project management
• Identifies performance / quality issues to develop appropriate remediation plan
• Identifies and escalates system or process issues hindering delivery
• Overseas the creation and detailing of study activity / source documents
• Supervises / monitor the initiation and quality control of all study related activities for assigned protocols
• Initiates and manages all operational study activities
• Provides critical operational and feasibility input to study design
• Contributes to the protocol development
• Aligns and influences study level operational strategies across programs and partner lines
• Provides critical assessment of strategic partner and vendor proposals to ensure study success
• Ensures appropriate level of oversight is maintained utilising escalation plans and providing resolution to issues at the study level
• Forecasts site level clinical trial budget
• Works proactively with other functions and strategic partners for timely delivery of quality data
• Oversees the overall execution of clinical studies
• Participates in study meeting with relevant partners for operational alignment
• Communicates opportunities and risks to the core project teams for integration in risk management plans
• Effectively coordinates all functional areas involved in clinical trials to solve problems and assure progress and timely completion of study goals
• Anticipates potential problems within a clinical trial and creates contingency plans accordingly
• Mentor and coach other clinical staff as needed
• Initiate general staff training activities
• Lead data management: manages all queries specific to subject data collection and supports in eHR setup activities
• May represent the unit on local or global initiatives (global SOP’s, process improvement teams, other activities as they present themselves) as they are the subject matter experts in the unit
• May lead clinical research unit teams accomplishing business needs and resolving issues
• May represent the clinical research unit as a subject matter expert for internal / external resource (provide support to external center, etc)
• Participate in study and staff scheduling for assigned protocols, as appropriate
• Oversee creation of detailing of study activity documents for staff and volunteer use