The Clinical Project Manager is responsible for the management of all aspects of the Clinical Trial Team activities as assigned project(s). The Clinical Project Manager, in close collaboration with the Project Leader, is accountable for achieving successful deliverables from the clinical team activities while meeting company and regulatory requirements according to time, quality, scope and within budget.
Responsibilities
Proactively manage project level operations, including but not limited to, aspects including management of trial timeline, budget, resources with consideration of quality standards and risk mitigation
Provide efficient and effective updates on trial progress to the Medical Director as requested
Lead sponsor study start-up processes, including but not limited to, conduct of the trial kick-off meeting, the set-up of trial master file (TMF), site selection and finalization of site and vendor Clinical Trial Agreements (CTAs) and budgets.
Ensure effective project plans are in place and operational for each trial. Proactively coordinate with the Clinical Trial Team to establish the priorities in accordance with applicable project plans, company standard operational procedures (SOPs), GCP guidelines and regulatory requirements.
Attend trial updat meetings, ensure meeting minutes are completed, distributed to team members and filed in the TMF in a timely manner. Review and approve site visit reports, ensure tracking, follow-up and resolution of site-specific issues have been completed in a timely manner.
Monitor the quality of deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team.
Qualifications
Education: Bachelor's degree in Life Sciences , Master in health related field is a plus
Languages: proficiency in oral and written english ( a third language would be appreciated)
Experience: minimum of three to five (5) years of clinical resarch experience in Project Management, Data Management or Clinical Monitoring. Previous experience in a pharmaceutical, CRO or medical device company required
Sound knowledge of GCP/CFR/ICH guidelines, ISO9001 and ISO14155
Personal skills
Ability to communicate, problem solve and work effectively in an international team
Innovative and self-motivated
Good organization skills and ability to prioritize goals and responsibilities
Ability to negotiate and communicate with clients in a professional manner
Proficient computer skills with the ability to understand and assess technology alternatives and implication for current processes
Ability to be productive and successful in a dynamic work environment
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Responsibilities
Proactively manage project level operations, including but not limited to, aspects including management of trial timeline, budget, resources with consideration of quality standards and risk mitigation
Provide efficient and effective updates on trial progress to the Medical Director as requested
Lead sponsor study start-up processes, including but not limited to, conduct of the trial kick-off meeting, the set-up of trial master file (TMF), site selection and finalization of site and vendor Clinical Trial Agreements (CTAs) and budgets.
Ensure effective project plans are in place and operational for each trial. Proactively coordinate with the Clinical Trial Team to establish the priorities in accordance with applicable project plans, company standard operational procedures (SOPs), GCP guidelines and regulatory requirements.
Attend trial updat meetings, ensure meeting minutes are completed, distributed to team members and filed in the TMF in a timely manner. Review and approve site visit reports, ensure tracking, follow-up and resolution of site-specific issues have been completed in a timely manner.
Monitor the quality of deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team.
Qualifications
Education: Bachelor's degree in Life Sciences , Master in health related field is a plus
Languages: proficiency in oral and written english ( a third language would be appreciated)
Experience: minimum of three to five (5) years of clinical resarch experience in Project Management, Data Management or Clinical Monitoring. Previous experience in a pharmaceutical, CRO or medical device company required
Sound knowledge of GCP/CFR/ICH guidelines, ISO9001 and ISO14155
Personal skills
Ability to communicate, problem solve and work effectively in an international team
Innovative and self-motivated
Good organization skills and ability to prioritize goals and responsibilities
Ability to negotiate and communicate with clients in a professional manner
Proficient computer skills with the ability to understand and assess technology alternatives and implication for current processes
Ability to be productive and successful in a dynamic work environment
