Clinical Operations Manager

2 settimane fa

Lazio, Italia Mygwork A tempo pieno

This job is with MSD, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.
Please do not contact the recruiter directly.
Job Description Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products.
We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.
This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Under the oversight of the COM Lead, the person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.
Responsibilities include, but are not limited to: Executes and oversees clinical trial country submissions and approvals for assigned protocols; Develops local language materials including local language Informed Consents and Translations; Interacts with IRB/IEC and Regulatory Authority for assigned protocols; Manages country deliverables, timelines and results for assigned protocols to meet country commitments.
Responsible for quality and compliance in assigned protocols in country; Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones; Collaborates closely with Headquarter to align country timelines for assigned protocols; Provide support and oversight to local vendors as applicable; Oversees and coordinates local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management.
E Enters and updates country information in clinical and finance systems; Contribute or lead initiatives and projects adding value to the business, as appropriate/required; Contributes strongly to COM team and other Country Operations roles knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
Contributes to COM team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required.
Education and Minimum Requirements: Bachelor's or advanced degree in science and/or with relevant work experience in direct site management (monitoring) in bio/pharma/CRO.
Required Experience and Skills:   Bachelor's Degree in Business Finance/ Administration/ Life Science; Expertise of core clinical systems, tools and metrics; Excellent verbal and written influencing and training/mentoring skills, in local language and English; Strong coordination and organizational skills; Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up; Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal support from the Sr.COM or manager.
Ability to make decisions independently with limited oversight from Sr.COM or manager.
Requires strong understanding of local regulatory environment Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.
Ability to lead a team of CTCs as applicable Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully  Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities.
All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.
No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place.
Where agency agreements are in place, introductions are position specific.
Please, no phone calls or emails.
Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 12/7/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date.
Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R324267 #LI-DNI

  • Manager, Clinical Operations

    1 mese fa

    Lazio, 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

    3 giorni fa

    Lazio, Italia Merck Gruppe - Msd Sharp & Dohme A tempo pieno

    Job Description Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical...

  • Clinical Operations Manager

    2 giorni fa

    Lazio, Italia Merck Gruppe - Msd Sharp & Dohme A tempo pieno

    Job Description Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products.We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical...

  • Clinical Operations Manager

    4 giorni fa

    Lazio, Italia Merck Gruppe - Msd Sharp & Dohme A tempo pieno

    Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical...

  • Clinical Project Manager

    1 settimana fa

    Lazio, Italia Clinchoice A tempo pieno

    Clinical Project Manager at Clin Choice (View all jobs) Italy Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds....Clin Choice, is searching for an experienced Senior Project Manager/Director to work with...

  • Regional Clinical Study Manager

    1 settimana fa

    Lazio, Italia Beigene A tempo pieno

    BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.General Description:Accountable for regional study...

  • Country Study Operations Manager I

    2 mesi fa

    Lazio, 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...

  • Clinical Project Manager

    1 settimana fa

    Lazio, Italia Clinchoice Inc. A tempo pieno

    Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds….Clin Choice is searching for an experienced Senior Project Manager/Director to work with one of our pharmaceutical partners, to oversee Clinical...

  • Clinical Project Manager

    2 mesi fa

    Lazio, Italia Clinchoice Inc. A tempo pieno

    Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring?Our team says it's the best of both worlds.... ClinChoice is searching for an experienced Senior Project Manager/Director to work with one of our pharmaceutical partners, to oversee Clinical Project...

  • Head Of In-Country Clinical Study Operations

    3 settimane fa

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

    Job Description: Head of In-Country Clinical Study Operations - Director - ItalyAs Head of In-Country Clinical Study Operations, you will:Provide leadership and drive performance.Steer strategic direction and ensure strong clinical operational oversight for all activities and personnel (inclusive of Functional Services Provider (FSP) team members) for...

  • Head Of In-Country Clinical Study Operations

    3 giorni fa

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

    Job Description: Head of In-Country Clinical Study Operations - Director - Italy As Head of In-Country Clinical Study Operations, you will: Provide leadership and drive performance. Steer strategic direction and ensure strong clinical operational oversight for all activities and personnel (inclusive of Functional Services Provider (FSP) team members) for...

  • Head Of In-Country Clinical Study Operations

    3 settimane fa

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

    Job Description: Head of In-Country Clinical Study Operations - Director - Italy As Head of In-Country Clinical Study Operations, you will:Provide leadership and drive performance.Steer strategic direction and ensure strong clinical operational oversight for all activities and personnel (inclusive of Functional Services Provider (FSP) team members) for...

  • Senior Clinical Project Manager

    7 giorni fa

    Lazio, Italia Clinchoice Inc. A tempo pieno

    Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds….Clin Choice is searching for an experienced Senior Project Manager to work with one of our pharmaceutical partners.This can be a home-based position,...

  • Senior Clinical Project Manager

    3 giorni fa

    Lazio, Italia Clinchoice Inc. A tempo pieno

    Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring?Our team says it's the best of both worlds.... ClinChoice is searching for an experienced Senior Project Manager to work with one of our pharmaceutical partners.This can be a home-based position,...

  • Clinical Trial Management Principal

    1 mese fa

    Lazio, Italia Vertex Pharmaceuticals A tempo pieno

    Job DescriptionGeneral Summary:The Clinical Trial Management Principal is responsible for leading global or regional-based activities on complex clinical trials across a range of study phases (Phases 1 through 4, including Real World Evidence trials) and therapeutic areas. In the global role, the Clinical Trial Management Principal leads the global...

  • Clinical Project Manager

    1 settimana fa

    Lazio, Italia Alira Health Group A tempo pieno

    Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration.Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.Job Description Summary FSP...

  • Clinical Trial Management Principal

    3 settimane fa

    Lazio, Italia Vertex Pharmaceuticals A tempo pieno

    Job Description General Summary: The Clinical Trial Management Principal is responsible for leading global or regional-based activities on complex clinical trials across a range of study phases (Phases 1 through 4, including Real World Evidence trials) and therapeutic areas. In the global role, the Clinical Trial Management Principal leads the global...

  • Clinical Project Director

    1 settimana fa

    Lazio, Italia Clinchoice A tempo pieno

    Clinical Project Director at Clin Choice (View all jobs) Italy Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds....Clin Choice, is searching for an experienced Senior Project Manager/Director to work...

  • Clinical Research Associate

    2 mesi fa

    Lazio, Italia Tfs Healthscience A tempo pieno

    CRA Italy - 0.2/0.4 FTE - FREELANCE About this role TFS Health Science is a leading global, mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey.Our expertise includes full service-capabilities, resourcing and functional service (FSP) solutions The...

  • Clinical Project Director

    2 mesi fa

    Lazio, Italia Clinchoice Inc. A tempo pieno

    Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring?Our team says it's the best of both worlds.... ClinChoice is searching for an experienced Senior Project Manager/Director to work with one of our pharmaceutical partners to oversee Clinical Project...