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Site Activation Partner II

1 mese fa

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

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.

To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.

Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

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. Responsibilities span within a country or multi-country depending on the geographical region and business needs.

ROLE RESPONSIBILITIESClinical Trial Site Activation & Conduct
  • Initiate and coordinate activities and essential documents management towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to sites initiation approval.
  • Register investigator sites in Pfizer registries and systems as required. Update and regularly maintain the registry with accuracy and have it inspection ready.
  • Work directly and interact with investigator sites to complete critical information and readiness for site activation; inclusive of but not limited to Investigator Initiation Packages (IIP) essential documents components, study contracts contacts, clinical supply shipment information, payment information, IRB submission and status.
  • Take the lead to resolve issues or concerns and timely escalation of issues where applicable.
  • Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572 revisions, for internal regulatory approval within required timelines.
  • Lead a subset and assist with the overall site activation process and coordinate operational activities to ensure timely site activation.
  • Take the Lead and Coordinate the compilation of the Central Investigator Review Board (IRB) package and submissions to approval of the study.
  • Coordinate the timely communication, documentation and responses between Pfizer and Central Ethics committee to bring clinical study to approval (country dependent).
  • Support investigator sites with local IRB workflow from preparation, submission through approval.
  • Assist with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information as needed.
  • Initiate and coordinate activities and essential documents management with the investigator’s sites (post SIV) during study conduct towards the compilation of a high-quality documents and updates through the life cycle of a study such as the documents management for protocol amendments, FDA 1572 revisions, Ethics Committee annual approvals.
  • Responsible for timely filing of documents to Trial Master File and other systems and assist with periodic quality review of study files for accuracy and completeness.
  • Accurately update and maintain clinical systems that track site compliance and performance within project timelines.
  • Lead or assist with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
  • Supports investigator sites, and study teams in preparation for and providing responses to site audits/inspections.
Communication
  • Maintain ongoing contact and communication with the study team and respond promptly to study team and investigator site requests.
  • Attend study Start-up meeting and provide functional updates on a country and site level.
  • Establish tools for efficient updates to study team as needed regarding site status, issues, delays, approvals.
  • Disseminate Central Ethics Approval to study team and Investigator Sites.
  • Communicate Local sites approvals to study team members and stakeholders.
Clinical Trial Site Support
  • As needed, perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with study documentation is in accordance with prevailing laws, Good Clinical Practices, and Pfizer standards.
  • Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel 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.
  • 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.
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 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.
  • Effective verbal and written communication skills in 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 require some international travel.

Flexibility

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.


LAST DAY TO APPLY: October 15th 2024

Purpose

Breakthroughs that change patients' lives... At Pfizer we are a patient-centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

One bold way we are achieving our purpose is through our company-wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

Disability Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here

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