Interested ? Don't hesitate to take a look at the job description below !
julie.licoppe@professionals.randstad.be
clinical project manager.
- anderlecht
- posted 20 january 2022
- closes 30 may 2022
key responsibilities
- 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
qualifications
- 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)
the application process.
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