Descripción de la oferta
pThe Senior Clinical Project Manager reports to the Clinical Operations Manager and is responsible to manage 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 on 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/escalating any out of scope. /ppbr/ppbr/ppstrongSome of what you'll that: /strong /ppbr/ppbr/pulliProactively manages and coordinates the overall project activities ensuring that the deliverable meet contractual requirements, timelines, and quality standard; /liliLeads the clinical project team and the various study team meetings; /liliOrganizes and prepares kick-of meeting, periodic meeting with Sponsor, Investigators’ meeting and internal project meetings ensuring that meeting minutes are appropriately filed in the Trial Master File; /liliProvides 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; /liliPrepares the project plans, study/investigation specific procedure and tools; /liliManages study/investigation IMP/IP/MD (i.e., re-supply/IMP/IP/MD expiration/re-labelling of IMP/IP/MD, etc.) Manages 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; /liliReviews and approves the Investigator’s Folder and Trial Master File prototype; /liliEnsures that the monitoring team is trained on study/investigation specific procedures and aspects; /liliEnsures that the enrolment curve is on-track and take actions in case of under-performance; Ensures that the monitoring activities are conducted as per monitoring plan requirements; /liliReviews and approves site/remote reports; /liliEnsures 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; /liliProperly and timely escalates relevant issues according to the relevant procedures; /liliEnsures potential study/investigation risks are assessed, managed, and communicated according to the relevant procedures. /liliManages the administrative aspects of studies/investigations, including study/investigation budget and interact with the Finance and Administrative Unit in case of extra-budgets are needed; Interacts with the Vendor Manager in evaluating vendors services based on study/investigation requirements; /liliManages the study/investigation vendors and monitor the quality of vendor deliverables, addresses quality issues with the appropriate team member and identifies opportunities to improve the execution of the activities; /liliReviews 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/all regulatory requirements and provides oversight to the study/investigation team regarding TMF filing, maintenance and archival procedures; /liliEnsures that the site TMFs are checked by the monitoring team according to OPIS and/or Sponsor procedures; /liliKeeps track of terminating studies and do the final check of the completeness of TMFs; /liliProvides support with proposal development and participates in client presentations and/or bid defense meetings, as required; /liliPerforms co-monitoring visits with CRAs, if necessary; /liliCan 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; /liliCollaborates in establishing and maintaining SOPs related to his/her activities; /liliCollaborates to on-boarding of new associates and act as a mentor of junior staff. /liliPerforms and completes on time all required trainings (training on OPIS and/or Sponsor SOPs, all other applicable trainings) by the assigned due date. /liliEnsures compliance of his/her study team on completing in due time all required assigned study-specific trainings; /liliEnsures that OPIS and Sponsors’ KPI/KQI are respected; /liliEnsures daily completion of TRACK system, correct entry of appropriate billable and non-billable time and ensure that the activities are billed on time /li /ulpbr/ppbr/ppstrongWhat you have: /strong /ppbr/ppbr/pulliDegree in a scientific field /liliAt least 7 years of experience as Clinical Project Manager /liliExcellent knowledge of ICH-GCP, ISO1455 and techniques for the monitoring of clinical trials /liliAble 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 /liliAble to work independently under the supervision of the Clinical Operations Manager /liliGood ability to manage and coordinate resources /liliExcellent knowledge of English language /liliAble to oversee the activities of CRAs /li /ulpbr/ppbr/ppstronguWho we are: /u /strong /p pbr/ppFounded 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. /ppOPIS 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. /ppbr/ppbr/p pstronguWhat we offer: /u /strong /p pbr/ppemWe offer a competitive salary with other benefits/bonuses and opportunity to develop your professional career with an expanding and growing company. /em /ppPlease read the information notice on the processing of personal data in the candidates information section of emour company website. /em /p
