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Country Study Operations Manager I

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Pfizer

7d ago

  • Job
    Full-time
    Mid & Senior Level
  • Research & Development
    Healthcare
  • Rome
  • Quick Apply

AI generated summary

  • You need relevant clinical trial experience, a technical degree, knowledge of GCP, strong project management skills, and expertise in risk mitigation and communication. Adaptability is key.
  • You will manage study activities from startup to close, oversee pCROs, coordinate with local teams, ensure compliance, resolve issues, and support recruitment and vendor management.

Requirements

  • Relevant operational clinical trial experience
  • A scientific or technical degree is preferred along with knowledge of clinical trial methodology
  • BA/BS 5+ years of relevant experience
  • MBA/MS 3+ years of relevant experience
  • BS/BSc/MS/MSc
  • Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility
  • English is required.
  • Demonstrated clinical research experience and/or study management/startup project manager experience
  • Demonstrated experience in managing country level operational activities and/or vendors
  • Experience in Study and Quality management and working in a matrix management environment
  • Expertise in the use of study/site dashboard and reporting tools
  • Detail oriented & possesses technical expertise
  • Ability to manage moderately complex processes
  • Ability to operate in a matrix environment
  • Risk Identification & Mitigation
  • Strategic Planning, Analytical and Problem-Solving Skills
  • Critical Path Analysis
  • Excellent communication skills, both written and verbal
  • Ability to adapt to changing technologies and processes

Responsibilities

  • Responsible for management/oversight of study and regional/country level activities from study startup through conduct and study close
  • May manage the study start up process in countries assigned (where SUPM not assigned) and/or oversee pCRO responsible for these activities as applicable
  • Through the Site Care Partner/Country Trial Manager or pCRO supports the Country/investigator outreach process, site identification and feasibility ensuring countries/sites can meet all study protocol requirements
  • Provides country level input on Startup and Recruitment milestones as provided by pCRO and/or Country Trial Manager/Site Care Partner to Global Study Manager during planning
  • Is accountable for overseeing pCRO and/or Country Trial Manager/Site Care Partner for assigned studies at country level in accordance with the overall project plan, manages and maintains accurate country level plans (e.g. timelines, budget, risk and quality plans)
  • Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required. Is also accountable for resolution of Site Activation escalations to Study Teams including offering options for mitigation
  • Leader of the Local Study Team (core members: (Lead) Site Care Partners Clinical Trial Assistant, ad hoc members: ICL, Site Activation Partner, CTRO and Local Regulatory, Medical Affairs colleagues and other key stakeholders as required)
  • Ensures compliance to relevant Global and Local, internal and external requirements and regulations
  • Ensures timely communication bidirectionally between the global and local study team.
  • Provides protocol level guidance and support to responsible Local Study Team members as applicable.
  • Liaise with Site Care Partner, Lead Site Care Partner, Site Activation Partners and Regulatory colleagues in country to agree on submission strategy to Health Authorities and Ethic Committees
  • Utilizes roles in country such as Lead Site Care Partner, and expert roles such as Contracts Leads, Site Activation Partners to provide the Global Teams with local intelligence and operational nuances to be considered
  • Acts as the study level point of contact for all study-level questions for the Local Study Team, ensuring resolution at lowest possible level, and when needed liaising with and escalating to appropriate global roles/teams
  • Follows up on region/country level issue status to ensure resolution.
  • Identifies country level trends to improve deliverables processes as needed
  • Utilizes country intelligence to provide input on country specific risks into preparation of Investigational Quality Management Plan, Study Monitoring Plans, ensures PTMF completeness and oversight of all relevant compliance activities for allocated studies
  • Ensures audit/Inspection readiness during start-up and conduct
  • Manages applicable Quality Events with pCRO and local team as applicable and required
  • Coordinates effective site recruitment planning to allow for implementation of plans at the country and site level, consistent with global plan and local targets
  • Responsible to drive and ensure delivery of data cleaning deliverables for pCRO and sites as applicable
  • Provides input on Country level Per Subject Costs, local vendor costs and other fees where applicable
  • May act as a Subject Matter Expert
  • May lead operational effectiveness initiatives at country or regional level
  • Responsible for PTA and SIV report review for reports completed by the Site Care Partner
  • Supports implementation of Pfizer's Site Technology Experience systems (e.g. Shared Investigator Platform SIP, Centralized Account Management CAM)
  • Support to EC/RA and other relevant (e.g. radiation, biobank) submissions and deficiency/query responses for initial and subsequent CTA submissions within required timelines
  • Drives pCRO and/or applicable internal study team members to ensure PTMF set up meets study requirements, and maintains oversight of PTMF completeness
  • Provides country level documents to PTMF and maintains oversight of Investigator Site File (ISF) reconciliation and completeness actions
  • Ensures pCRO and/or applicable internal study team members maintain appropriate level IP/equipment/ancillary supplies management including Import/Export License management with the support of Clinical Trial Assistants and other roles as required
  • Supports implementation of new tools and technologies (e.g. eConsent, eISF, Remote Source Access, remote SDV/SDR, iConnect, implementation of protocol required decentralized trial options etc.)
  • Support Identification, contract development and management of local vendors or facilities as per protocol
  • Investigator Meeting support and management including doing presentations as appropriate
  • Management of local Investigator Meetings including doing presentations as appropriate

FAQs

What is the primary role of the Country Study Operations Manager I - Italy?

The primary role is to manage study and regional or country-level activities from startup through conduct and close, overseeing studies of limited complexity or specific parts of larger studies.

Who does the Country Study Operations Manager I report to?

The Country Study Operations Manager I reports to Lorenzo Majerini, the Director/Supervisor of Study Management.

What qualifications are preferred for this position?

A scientific or technical degree is preferred, along with knowledge of clinical trial methodology and relevant operational clinical trial experience.

What type of experience is required for this position?

Candidates should have a demonstrated clinical research experience, study management/startup project manager experience, and experience in managing country level operational activities and/or vendors.

What specific skills are necessary for the role?

Necessary skills include expertise in study/site dashboard and reporting tools, risk identification and mitigation, strategic planning, analytical and problem-solving skills, and excellent communication skills.

Will I be leading a team as a Country Study Operations Manager I?

Yes, you will be the leader of the Local Study Team, which includes core members such as Site Care Partners and other key stakeholders as needed.

How does this position contribute to compliance?

The Country Study Operations Manager I ensures compliance with relevant Global and Local, internal and external requirements and regulations throughout the study process.

What is the job's approach to vendor management?

The role includes responsibility for study and/or country vendor management and oversight, including follow-up and coordination of vendor deliverables.

Is there an emphasis on communication within this role?

Yes, the role requires timely communication between the global and local study teams and with internal stakeholders to ensure efficient study delivery throughout the study lifecycle.

Are there opportunities for professional development in this position?

Yes, the position may involve leading operational effectiveness initiatives and contributing to strategic planning, which can enhance professional growth.

What is the work environment like in this role?

The role operates in a matrix environment, requiring collaboration with multiple stakeholders and the ability to adapt to changing technologies and processes.

Are there expectations for the Country Study Operations Manager I concerning audit readiness?

Yes, the position requires ensuring audit/inspection readiness during startup and conduct phases of the study.

Pfizer

Pharmaceutical Manufacturing

Science & Healthcare
Industry
10,001+
Employees
1849
Founded Year

Mission & Purpose

Pfizer is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative healthcare solutions. They are committed to improving the health and well-being of people around the world. Pfizer's mission is to be a leading force in the fight against diseases and to provide access to safe, effective, and affordable medicines. Their purpose is to make a positive impact on society by advancing medical science, developing breakthrough therapies, and collaborating with healthcare professionals and partners to address unmet medical needs. With a focus on research, development, and the production of pharmaceutical products, Pfizer plays a vital role in shaping the future of healthcare and improving patient outcomes.