Head of In-country Clinical Study Operations

5 mesi fa

Roma, Italia Merck KGaA A tempo pieno

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you've got big plans '“ so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your role:
As Head of In-Country Clinical Study Operations - Director - Italy you will provide leadership, drive performance, steer strategic direction and ensure strong clinical operational oversight for all activites and personnel (inclusive of Functional Services Provider (FSP) team members) for assigned country; you will be accountable for ensuring the development of long-term relationships with clinical investigators and sites, enhancing the image and reputation of the company and for providing an interface between the company and the CRO at the country level; you will act as a point of escalation and critical interface with our external partners at the country level to drive adherence to timelines/budgets as well as resolve functional concerns or trends contributing to delivery challenges/issues; you will be accountable for aligning on priorities at the local level with medical and commercial organization for clinical development and life-cycle management plans/strategies; you will strongly contribute to the overall performance of own department, recommending strategies for new systems, tools, and processes, enhancing efficiencies and effectiveness to improve the clinical study delivery process and elevate country performance in collaboration with other functions; ensure proper conduct and support for any inspections (e.g. from Health authorities) applicable for the Local or Global department; continuously monitor performance of assigned staff against applicable practices and expectations, addressing any deficiency and providing coaching and mentoring as required in order to establish and maintain high performing teams.

Who you are:

- Substantial (10+ years) professional experience in Clinical Research in biotech, pharma or CRO, including experience in Clinical Trial Management and working in or managing Clinical Monitoring/Site Management
- Ability to work independently on assigned tasks or projects of increasing complexity/ sensitivity
- Ability to assess risk, solve problems and make decisions
- Demonstrated excellent organizational ability: time management, prioritization, able to handle and oversee multiple tasks simultaneously
- Strategic thinking beyond own function; is familiar with and considers overall business objectives and company strategy
- Outsanding ability to lead, mentor and manage teams and to direct, influence and motivate people
- Ability to work and navigate effectively in a matrix organization
- Approaches change positively; adapts behaviour or work methods in response to new information, changing conditions, or unexpected obstacle
- Strong cultural awareness
- Fluency in Italian and English (oral and written) - other regional languages appreciate Available to travel in Italy and abroad up to 30% of time
-

**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress

  • Head of Clinical Study Operations Director

    1 settimana fa

    Roma, Lazio, Italia Https:Www.Energyjobline.ComSitemap A tempo pieno

    Job Title: Head of Clinical Study Operations Director - Director - ItalyThe Head of Clinical Study Operations Director will provide leadership, drive performance, and steer strategic direction for all activities and personnel (including Functional Services Provider (FSP) team members) for the assigned country.This role will be accountable for developing...

  • Senior Clinical Study Operations Manager

    2 settimane fa

    Roma, Lazio, Italia Https:Www.Energyjobline.ComSitemap A tempo pieno

    Job Title: Head of In-Country Clinical Study OperationsAbout the Role:We are seeking a highly experienced and skilled Head of In-Country Clinical Study Operations to lead our clinical research operations in Italy. As a key member of our team, you will be responsible for providing strategic direction and leadership to our clinical study operations, ensuring...

  • Clinical Study Operations Director

    3 settimane fa

    Roma, Lazio, Italia Merck Kgaa, Darmstadt, Germany A tempo pieno

    Job Title: Head of In-Country Clinical Study OperationsAs a key member of our team, you will be responsible for providing leadership and strategic direction for all clinical study operations in Italy. Your primary focus will be on ensuring the successful execution of clinical trials, building strong relationships with clinical investigators and sites, and...

  • Country Study Operations Manager I

    3 settimane fa

    Roma, Italia Pfizer, S.A. de C.V A tempo pieno

    Country Study Operations Manager I - Italy will report into Lorenzo Majerini Director/Supervisor of Study Management JOB SUMMARY The Study Operations Manager will have responsibilities for study and regional or specific country level activities from study startup through conduct and study close. The Study Operations Manager has responsibility for study...

  • Country Study Operations Manager I

    1 settimana fa

    Roma, Lazio, Italia Pfizer, S.A. De C.V A tempo pieno

    Job SummaryThe Study Operations Manager will be responsible for managing study and regional or specific country level activities from study startup through conduct and study close. This role will oversee the study start up process in countries assigned, manage the operational delivery of responsible tasks within one or more studies, and ensure compliance to...

  • Head of Clinical Operations

    5 mesi fa

    Roma, Italia MSD A tempo pieno

    We are excited to announce a fantastic opportunity for an experienced professional to join our team as the Head of Clinical Operations. In this critical leadership role, you will be accountable for the overall execution and oversight of local operational clinical trial activities, ensuring strict adherence to ICH/GCP guidelines, country regulations, and our...

  • Clinical Study Operations Director

    1 settimana fa

    Roma, Lazio, Italia Https:Www.Energyjobline.ComSitemap A tempo pieno

    Job Summary:The Head of In-Country Clinical Study Operations will provide leadership and strategic direction for all clinical activities and personnel in the assigned country. This role will ensure strong clinical operational oversight, drive performance, and develop long-term relationships with clinical investigators and sites.Key Responsibilities:Provide...

  • Country Study Operations Manager I

    4 settimane fa

    Roma, Italia Pfizer A tempo pieno

    Country Study Operations Manager I - Italy will report into Lorenzo Majerini Director/Supervisor of Study Management JOB SUMMARY The Study Operations Manager will have responsibilities for study and regional or specific country level activities from study startup through conduct and study close. The Study Operations Manager has responsibility for study...

  • Country Study Operations Manager I

    3 settimane fa

    Roma, Italia Pfizer A tempo pieno

    Country Study Operations Manager I - Italy will report into Lorenzo Majerini, Director/Supervisor of Study Management. JOB SUMMARY The Study Operations Manager will have responsibilities for study and regional or specific country level activities from study startup through conduct and study close. The Study Operations Manager has responsibility for study...

  • Senior Clinical Study Operations Director

    3 giorni fa

    Roma, Lazio, Italia Merck Kgaa, Darmstadt, Germany A tempo pieno

    Role OverviewAs a seasoned professional in Clinical Research, you will lead the In-Country Clinical Study Operations team in Italy, providing strategic direction and ensuring strong clinical operational oversight for all activities and personnel. Your expertise will be crucial in driving performance, developing long-term relationships with clinical...

  • Country Study Operations Manager

    2 settimane fa

    Roma, Lazio, Italia Pfizer A tempo pieno

    Job Summary: We are seeking a highly skilled Country Study Operations Manager to join our team at Pfizer. The successful candidate will be responsible for managing study and regional/country level activities from study startup through conduct and study close. This role will involve overseeing the study start up process, managing vendors, and ensuring...

  • Pod Vice President Head of Oncology Global Study and Site Operations

    3 settimane fa

    Roma, Lazio, Italia Pfizer, S.A. De C.V A tempo pieno

    Job DescriptionPfizer, S.A. De C.V is seeking a highly skilled and experienced professional to fill the role of Pod Vice President Head of Oncology Global Study and Site Operations. This position will be responsible for establishing the strategic vision and short to long-term planning for Oncology Global Study and Site Operations within their region.The...

  • Senior Clinical Study Operations Director

    3 settimane fa

    Roma, Lazio, Italia https:www.energyjobline.comsitemap A tempo pieno

    Job Title: Senior Clinical Study Operations DirectorAs the Senior Clinical Study Operations Director, you will be responsible for leading the clinical study operations team in Italy. Your primary goal will be to drive performance, steer strategic direction, and provide leadership for all activities and personnel.Key Responsibilities:Develop long-term...

  • Clinical Operation Manager

    5 mesi fa

    Roma, Italia EastHORN Clinical Services A tempo pieno

    **Job summary**: As an experienced **Clinical Operations Manager **you will be expected to develop and grow the team in France and support clients relationships for the assigned region. Reporting to the Executive Director Clinical Operations, you will be a key member of the **Clinical Operations team.** We are searching for an experienced, ambitious and...

  • Senior Director of Clinical Site Operations

    3 settimane fa

    Roma, Lazio, Italia Pfizer A tempo pieno

    Job SummaryPfizer is seeking a highly experienced Senior Director of Clinical Site Operations to join our team. As a key member of our Site Country Operations team, you will play a critical role in delivering strategic vision and representing Pfizer operations at the country or cluster level.The ideal candidate will have a strong background in clinical...

  • Clinical Research Associate, Italy

    7 mesi fa

    Roma, Italia EastHORN Clinical Services A tempo pieno

    **Job summary**: As a **Clinical Research Associate **you will be expected to actively participate in and manage the recruitment of potential investigators and perform CA and EC submissions. You will be responsible for monitoring of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, liaison with vendors and other duties....

  • Manager, Clinical Operations

    1 settimana fa

    Roma, Italia Alnylam Pharmaceuticals Inc. A tempo pieno

    Job Description - Manager, Clinical Operations (240110) Manager, Clinical Operations ( Job Number: 240110 ) Overview Responsible for aspects of clinical development planning and strategy, clinical study planning and execution within pre-specified clinical development program, timelines and budget and includes, but is not limited to, preparation of study...

  • Clinical Operations Manager

    5 mesi fa

    Roma, Italia MSD A tempo pieno

    This role is accountable for performance and compliance for assigned protocols in a country, in compliance with ICH/GCP and country regulations, company’s policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Sr. COM, Head COMs or CRD, the person is responsible for...

  • Clinical Research Associate

    5 mesi fa

    Roma, Italia MSD A tempo pieno

    The role of Clinical Research Associate is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our Company policies and procedures, quality standards and adverse event reporting requirements...

  • Sr. Clinical Research Associate

    5 mesi fa

    Roma, Italia MSD A tempo pieno

    The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, our company’s policies and procedures, quality standards and adverse event reporting requirements internally and...