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. He/she leads the internal study team and ensures all deliverables meet expectations and milestones. Establishes strategies with the study team to achieve study/investigation commitments. Collaborates with major functional areas to identify and evaluate potential project issues and ensures timely solutions. Proactively manages operational aspects of the project including trial timeline, budget, and vendors. Forecasts units/hours/resources for monitoring activities and analyzes forecasted versus worked activities to ensure contract and budget adherence, identifying and escalating any out-of-scope items.
Presente su candidatura después de leer los siguientes requisitos de habilidades y cualificaciones para este puesto.
Some of what you'll that:

Proactively manages and coordinates overall project activities ensuring 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 Sponsor, Investigators' meeting and internal project meetings ensuring that meeting minutes are filed in the Trial Master File.
Provides efficient updates on study/investigation progress to Sponsor and internal team; prepares feasibility questionnaires and ensures site feasibility and qualification process for qualified investigational sites is conducted as per requirements and within timelines.
Prepares project plans, study/investigation specific procedures and tools.
Manages study/investigation IMP/IP/MD and related materials; collaborates with Regulatory and Submission team to speed up regulatory process and site contract negotiation.
Reviews and approves the Investigator's Folder and Trial Master File prototype.
Ensures monitoring team is trained on study/investigation specific procedures.
Ensures enrolment curve is on track and takes action in case of under-performance; ensures monitoring activities comply with monitoring plan requirements.
Reviews and approves site/remote reports.
Ensures site issues are tracked, followed up and resolved timely; proposes and guarantees action plans that resolve issues and/or improve processes.
Properly and timely escalates relevant issues per procedures.
Ensures potential study/investigation risks are assessed, managed, and communicated as per procedures.
Manages administrative aspects including study/investigation budget and coordinates with Finance and Administrative Unit for extras; interacts with Vendor Manager to evaluate vendor services.
Manages study/investigation vendors, monitors quality of vendor deliverables, addresses quality issues, and identifies improvement opportunities.
Reviews vendor invoices and ensures hospital fees paid per contractual requirements.
Ensures all project‑level documentation is filed in the TMF per SOPs/regulatory requirements and provides oversight to team regarding TMF filing, maintenance and archival procedures.
Ensures site TMFs checked by monitoring team per OPIS/Sponsor procedures.
Keeps track of terminating studies and performs final check of TMF completeness.
Provides support with proposal development and participates in client presentations and/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.
Collaborates in establishing and maintaining SOPs related to activities.
Collaborates on onboarding of new associates and mentors junior staff.
Performs and completes all required trainings by assigned due date.
Ensures study team completes required assigned trainings on time.
Ensures OPIS and Sponsor KPI/KQI respected.
Ensures daily TRACK system completion, correct entry of billable/non‑billable time and ensures activities billed on time.

What you have:

Degree in a scientific field.
At least 7 years of experience as Clinical Project Manager.
Excellent knowledge of ICH‑GCP, ISO1455 and techniques for monitoring clinical trials.
Able to coordinate all activities related to management of local and international projects, monitoring of clinical studies/clinical investigations, guaranteeing security of information.
Able to work independently under the supervision of the Clinical Operations Manager.
Good ability to manage and coordinate resources.
Excellent knowledge of English language.
Able to oversee activities of CRAs.

Who we are:
Founded in 1998 in Italy and now operating at an international level, 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 added value lies in its highly specialized professionals who can assist clients using their deep know‑how and experience to guarantee a top‑quality level of Clinical Trial Management and ability to operate in a wide range of fields (medical writing, scientific and statistical consultancy for trial design, regulatory activities, pharmacovigilance, etc.) always contributing to our clients' challenging achievements.
What we offer:
We offer a competitive salary with other benefits/bonuses and an opportunity to develop your professional career with an expanding and growing company.
Please read the information notice on the processing of personal data in the candidates information section of our company website.
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