Descripción de la oferta
The Senior Clinical Project Manager reports to the Clinical Operations Manager and is responsible for managing the 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 allocated to his/her projects ensuring that all deliverables meet agreed expectations and milestones. Establishes with the study team strategies for achieving the study/investigation commitment. Collaborates with major functional areas to identify and evaluate potential issues on the project and ensures the implementation of timely solutions. Proactively manages project‑level operational aspects including management of trial timeline, budget, and vendors. Forecasts units/hours/generic resources for monitoring activities and analyzes forecasted and worked activities to ensure adherence to contract and budget, identifying and escalating any out‑of‑scope items.
Responsibilities
Proactively manages and coordinates the overall project activities ensuring that the deliverables meet contractual requirements, timelines, and quality standards.
Leads the clinical project team and the various study team meetings.
Organizes and prepares kick‑off meetings, periodic meetings with Sponsor, Investigators' meetings and internal project meetings, ensuring that meeting minutes are appropriately filed in the Trial Master File.
Provides efficient updates on study/investigation progress to the Sponsor and to the internal team; prepares feasibility questionnaires and ensures that the site feasibility and qualification process for identification of qualified investigational sites is conducted as per study/investigation requirements and within timelines.
Prepares the project plans, study/investigation specific procedures and tools.
Manages study/investigation IMP/IP/MD (re‑supply, IMP/IP/MD expiration/re‑labelling, etc.) and study/investigation materials (questionnaires, sample kit, etc.). Collaborates effectively with the Regulatory and Submission team to speed up the regulatory process and site contract negotiation.
Reviews and approves the Investigator's Folder and Trial Master File prototype.
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 the monitoring activities are conducted as per monitoring plan requirements.
Reviews and approves site/remote reports.
Ensures tracking, follow‑up and resolution of site issues have been completed in a timely manner; proposes and guarantees the implementation of action plans that resolve issues and/or improve processes.
Properly and timely escalates relevant issues according to the relevant procedures.
Ensures potential study/investigation risks are assessed, managed, and communicated according to the relevant procedures.
Manages the administrative aspects of studies/investigations, including study/investigation budget and interacts with the Finance and Administrative Unit when extra budgets are needed; interacts with the Vendor Manager in evaluating vendor services based on study/investigation requirements.
Manages the study/investigation vendors and monitors the quality of vendor deliverables, addresses quality issues with the appropriate team member and identifies opportunities to improve the execution of the activities.
Reviews vendor invoices and ensures that hospital fees are paid as per contractual requirements; ensures all project‑level study/investigation documentation is filed in the TMF in accordance with company SOPs and all regulatory requirements and provides oversight to the study/investigation 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.
Keeps track of terminating studies and does the final check of the completeness of TMFs.
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 (e.g., back‑up or directly allocated to the site), if he/she is compliant with local minimum requirements for monitoring.
Collaborates in establishing and maintaining SOPs related to his/her activities.
Collaborates to onboard new associates and act as a mentor of junior staff.
Performs and completes on time all required trainings (training on OPIS and/or Sponsor SOPs, all other applicable trainings) by the assigned due date.
Ensures compliance of his/her study team on completing in due time all required assigned study‑specific trainings.
Ensures that OPIS and Sponsors' KPI/KQI are respected.
Ensures daily completion of TRACK system, correct entry of appropriate billable and non‑billable time and ensures that the activities are 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 the monitoring of clinical trials.
Able to coordinate all the activities related to the management of local and international projects, monitoring of clinical studies/clinical investigations, guaranteeing the 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 the 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 their 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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