Clinical Research Manager – Italy, Permanent, Home Based opportunity!
Clintec are recruiting for a Clinical Research Manager to join our growing CRO in Italy. This role is primarily accountable for the end to end performance for assigned protocols in Italy in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Main Point of Contact (POC) for assigned protocols and link between Country Operations (CO) and clinical trial team (CTT).
Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
Performs Quality control visits as required
Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration
Responsible for creating and executing a local risk management plan for assigned studies
Ensures compliance with CTMS, eTMF and other key systems in assigned studies
Escalates as needed different challenges and issues
Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies
Country POC for programmatically outsourced trials for assigned protocols.
Serves local business needs as applicable in his/her country (If delegated can sign contracts and manage budgets)
Collaborates internally with HQ functions and locally with internal stakeholders to align on key decisions in his/her studies.
As a customer-facing role, this position will build business relationships and represent company with investigators
Shares protocol-specific information and best practices across countries\clusters
Bachelor’s degree in science (or comparable)
Advanced degree, (e.g., Master degree, MD, PhD)
Strong Clinical Research Experience including previous CRA experience
Knowledge in Project/Site Management.
Strong organizational skills with demonstrated success required.
Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments
Requires strong understanding of local regulatory environment
Strong scientific and clinical research knowledge is required
Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
Strong leadership skills
Ability to identify problems, conflicts and opportunities early and lead, analyse and prepare mitigation plans and drive conflict resolution is critical.
Required to negotiate skilfully in tough situations with both internal and external groups; settle differences with minimum noise
Educational/pedagogic, diplomatic and empathic skills to effectively build and maintain professional relationships with investigators and other external stakeholders
Clintec is a dynamic, UK headquartered, privately owned, full service Contract Research Organisation with a presence in over 50 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assisting in their key product development efforts for over two decades. At Clintec we have experience in managing clinical trials in all major therapeutic areas including oncology, rare disease, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.
Clintec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process from the CRO perspective. We have strong partnerships with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. Clintec offers a competitive salary and rewards package.