Descripción del trabajo: The Senior Clinical Project Manager reports to the Clinical Operations Manager and is responsible for managing local and international projects in compliance with contractual requirements, timelines, standard operating procedures, and relevant regulations and legislations. The manager leads the internal study team, ensuring all deliverables meet agreed expectations and milestones, and collaborates with major functional areas to identify and evaluate potential project issues and implement timely solutions.
Responsabilidades
- Proactively manages and coordinates overall project activities ensuring that deliverables meet contractual requirements, timelines, and quality standards.
- Leads the clinical project team and various study team meetings.
- Organizes and prepares kick‑off meetings, periodic meetings with Sponsors, investigators’ meetings, and internal project meetings, ensuring that meeting minutes are appropriately filed in the Trial Master File.
- Prepares feasibility questionnaires and ensures that the site feasibility and qualification process for identifying qualified investigational sites is conducted according to study/investigation requirements and within timelines.
- Prepares the project plans, study/investigation specific procedures, and tools.
- Collaborates effectively with the Regulatory and Submission team to speed up the regulatory process and site contract negotiation.
- Ensures that the monitoring team is trained on study/investigation specific procedures and aspects.
- Ensures that the enrolment curve is on track and takes actions in case of under‑performance.
- Ensures that monitoring activities are conducted as per the monitoring plan requirements.
- Reviews and approves site/remote reports.
- Manages the administrative aspects of studies/investigations, including study/investigation budgets, and interacts with the Finance and Administrative Unit if extra budgets are needed.
- Interacts with the Vendor Manager to evaluate vendor services based on study/investigation requirements.
- Manages study/investigation vendors and monitors the quality of vendor deliverables, addressing quality issues with the appropriate team member and identifying opportunities to improve execution.
- Reviews vendor invoices and ensures that hospital fees are paid as per contractual requirements.
- Ensures that all project‑level study/investigation documentation is filed in the TMF in accordance with company SOPs and regulatory requirements and provides oversight to the team regarding TMF filing, maintenance, and archival procedures.
- Ensures that the site TMFs are checked by the monitoring team according to OPIS and/or Sponsor procedures.
- Provides support with proposal development and participates in client presentations or bid defense meetings as required.
- Performs co‑monitoring visits with CRAs if necessary.
- Can conduct feasibility, pre‑study visit, site initiation visit, monitoring visit, or close‑out visit as necessary, either as a backup or directly allocated to the site, if compliant with local minimum monitoring requirements.
- Collaborates in onboarding new associates and acts as a mentor for junior staff.
- Performs and completes all required training (training on OPIS and/or Sponsor SOPs, and all other applicable training) by the assigned due date.
- Ensures compliance of the study team in completing all required assigned study‑specific training on time.
Calificaciones
- At least 7 years of experience as a Clinical Project Manager.
- Excellent knowledge of ICH‑GCP, ISO1455, and techniques for the monitoring of clinical trials.
- Ability to coordinate all activities related to the management of local and international projects, monitoring of clinical studies/investigations, guaranteeing the security of information.
- Capability to work independently under the supervision of the Clinical Operations Manager.
- Excellent knowledge of the English language.
Acerca de la empresa
Founded in 1998 in Italy and now operating internationally, OPIS is a full‑service, science‑driven biotech‑focused CRO providing premium trial management for multi‑country clinical trials, including state‑of‑the‑art information technology solutions and innovative approaches to the increasing complexity and variety of current projects. OPIS adds value through its highly specialized professionals who can assist clients using deep know‑how and experience to guarantee top‑quality clinical trial management and the ability to operate in a wide range of fields (medical writing, scientific and statistical consultancy for trial design, regulatory activities, pharmacovigilance, etc.). Please read the information notice on the processing of personal data in the candidates’ information section of our company website.
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