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Site Activation Partner II

2 mesi fa

Florence, Italia Pfizer A tempo pieno
Site Activation Partner II

JOB SUMMARY

The Site Activation Partner is responsible for leading or supporting operational activities from start-up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and Pfizer standards. Responsibility spans within a country or multi-country depending on the geographical region and business needs.

ROLE RESPONSIBILITIES

Clinical Trial Site Activation

  • Initiate and coordinate activities and essential documents management towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for sites initiation.
  • Provide support to resolve issues or concerns and timely escalation of Site issues where applicable.
  • Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, FDA 572/Attestation Form, for internal regulatory approval within the required timelines.
  • Manage and coordinate with other supporting roles to ensure timely site activation and operational activities.
  • Take the Lead, initiate and coordinate activities related to the compilation of high-quality IRB/EC package and ensure timely submission to approval (Central and or Local and in countries where applicable), and other committees as per country requirements.
  • Collaborate with in-country regulatory groups, and provide related/applicable site documents, as well as in countries where parallel submissions (Regulatory authority and ethics) are required.
  • Coordinate the timely communication, documentation and responses between Pfizer and Central Ethics committee to bring clinical study to approval (country dependent).
  • Support investigators sites with local IRB workflow from preparation, and submission through approval.
  • Lead or assist with the preparation, handling, and distribution of clinical documentation and reports according to the scope of work and standard operating procedures.
  • Support & implement activities in Shared Investigator Platform to align with Pfizer strategy as it relates to the role.

Clinical Trials Conduct

  • Post site activation, initiate and coordinate activities and essential documents management with the investigator’s sites towards the compilation of high-quality documents and updates through the life cycle of a study such as the documents management for protocol amendments, FDA 1572/Attestation revisions, Ethics Committee annual approvals and other activities required during study conduct.
  • Ensure continuation of IRB/Ethic’s and other committees activities Post SIV, and related submission, notifications, re-approvals etc.
  • Responsible for timely filing of documents to Trial Master File and assisting with periodic quality review of study files for accuracy and completeness.
  • Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines.
  • Supports investigator sites, and study teams in preparation for and providing responses to site audits / inspections.

Internal & External Communication

  • Maintain ongoing contact and communication with the study team and respond promptly to study team and investigator site requests.
  • Provide functional updates on a country and site level as required.
  • Establish tools for efficient updates to study team as needed regarding site status, issues, delays, approvals.
  • Disseminate Central or Local Ethics Approval to study team and Investigator Sites where applicable.
  • Communicate Local sites approvals to study team members and stakeholders.

Clinical Trial Site Support

  • As needed, perform awareness sessions on Pfizer requirements with site personnel to ensure ongoing compliance with study documentation in accordance with prevailing laws, Good Clinical Practices, and Pfizer standards.
  • Identify and resolve investigator site issues within required timeframes; align with study team and local country colleagues on corrective and preventative actions to close open issues and to prevent recurrence / persistence of issues.

Additional Responsibilities:

  • Deep understanding of the Site Activation requirements and processes within the country and be able to develop and implement in more than one (1) country to enable multi-country coverage.
  • Assigned as Site Activation Partner Point of Contact (PoC) on a study conducted in multi-country: Represent the SAP role on the study; Take the lead in the compilation and preparation of the Investigator Initiation Package (IIP) Template for the study and share with SAP team globally; Communicate with SAPs globally on study information and timelines.
  • Be an SME on one or more system and/or process, be the go-to person and train the SAPs on these respective systems or processes.
  • Represent the SAP role on global initiatives.
  • Able to act as an SME on projects and initiatives, as requested.
  • Mentor for new hires on processes, systems and SAP activities facilitating and optimizing the time from hire/training to assignment on a study.
  • Able to manage a high volume of, complex studies and sites.

Systems & Tools

  • Ability to use and learn systems, and to use independently.
  • Ethics, National Networks and Governing Bodies Portals and platforms.
  • Electronic Investigator Site File (e.g. Florence).
  • Microsoft Suite.
  • Clinical Trial Management Systems (CTMS).
  • Electronic Trial Master File.
  • Document exchange portals.
  • Shared Investigator Platform.

BASIC QUALIFICATIONS

  • School diploma/certificate with equivalent combination of education, training and experience; BS/BA or bachelor’s degree in life sciences preferred.
  • Minimum 4 years relevant experience in Clinical Trials environment and clinical site activation. Experience working in the pharmaceutical industry/or CRO is an asset.
  • Demonstrated deep knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations.
  • Must be fluent in Local language and in English.
  • Multilingual capability is an asset.
  • Effective verbal and written communication skills relating to colleagues and associates both inside and outside of the organization.
  • Good technical skills and ability to learn and use multiple systems.
  • Experience working in a global environment.
  • Experience in working in more than 1 country is an asset.
  • Experience in leading or participating as an active member of cross functional teams, task forces, or local.

PHYSICAL/MENTAL REQUIREMENTS

  • Demonstrated knowledge and understanding of key operational elements of a clinical trial and processes (e.g., study start-up, conduct, close-out activities, reporting, etc.) and ability to gain command of these processes.
  • Understand the quality expectations and emphasis on right first time. Demonstrate compliance with all applicable company, regulatory and country requirements. Attention to detail evident in a disciplined approach.
  • Proven ability to work independently and also as a team member.
  • Ability to organize tasks, time and priorities, ability to multi-task.
  • Understand basic medical terminology, GCP requirements and proficient in computer operations.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • Flexible and adapt to off working hours in a global environment (when applicable).
  • Possible Travel within area. May include some international travel.

ORGANIZATIONAL RELATIONSHIPS

  • Global Study Manager and Start-Up Project Manager, Global Study Clinician.
  • Local Site Relationship Partners and Director Clinical Site Operations, Country Trials Manager and other Local Roles.
  • Global Investigator Initiation Package (IIP) Regulatory Group.
  • Local Regulatory Manager, CTA Hub and CTA Submission Managers.
  • Site Intelligence Team.
  • Contract specialists.
  • Investigators Sites.
  • Country Ethics Committee representatives.
  • Other governing bodies representatives.
  • Local provincial/States and national networks.

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Work Location Assignment: Remote - Field Based

EEO (Equal Employment Opportunity) & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.

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