Site Activation Partner

Why Patients Need You
A career with us is about discovering breakthroughs that change patients' lives. A high performing Site Activation team is essential to bringing those therapies to people all over the world. We need dedicated colleagues like you who focus on what matters, think big, find solutions, and collaborate to achieve our purpose.
What You Will Achieve
As a Site Activation Partner you are responsible for leading and 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 within a country or multiple countries.
How You Will Achieve It
Reporting to the Site Activation Partner Team Lead, the Site Activation Partner plays a key role in the following:
Clinical Trial Site Activation

• Take the Lead and coordinates activities related to compilation of high-quality IRB/EC package and ensure timely submission to approval and other committees as per country requirements
• Collaborate with in country regulatory group, and other stakeholders and provide related/applicable site documents as applicable
• Collaborate on the timely communication, documentation and responses between Pfizer and Ethics committees/sites to bring clinical study to approval
• 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
• Prepare, validate and submit essential documents for internal sponsor regulatory group approval within required timelines
• Manage and coordinate with other supporting roles to ensure timely site activation and operational activities.
• Support & implement activities in Shared Investigator Platform to align with Pfizer strategy
• Coordinate translation of documents that are within scope with preferred vendors
• Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines
• Responsible for timely filing of documents to Trial Master File and assisting with periodic quality review of study files for accuracy and completeness

Clinical Trials Conduct

• Ensure continuation of IRB/Ethic's and other committees activities Post SIV, and related submission, notifications, re-approvals etc..
• Post site activation, maintain the coordination of activities of essential documents updates and management with the investigator's sites through the life cycle of a study
• Maintain TMF and systems during study conduct
• Supports investigator sites, and study teams in preparation for and providing responses to site audits / inspections
• Additional Responsibilities may include:
• Being a Subject Matter Expert on one or multiple system and/or processes
• Support global initiatives as it pertains to the role and responsibilities
• Maintain high level of compliance on all activities

What we think you will need to be successful in this role:

• School diploma/certificate with equivalent combination of education, training and experience; BS/BA or bachelor's degree in life sciences preferred
• Strong relevant experience in Clinical Trials environment, Ethics environment and clinical site activation.
• Experience working in the pharmaceutical industry or CRO in a similar role
• Demonstrated deep knowledge of clinical trial methodologies, ICH/GCP, Global and local country regulations
• Deep understanding of the Site Activation requirements and processes within the country
• Must be fluent 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
• Excellent knowledge of MS suite and Good technical skills and ability to learn and use multiple systems as it pertains to the role (e.g. CTMS, Network portals, SIP etc.)
• Experience working in a global environment
• Experience in working in more than 1 country is an asset
• Ability to work under pressure to meet deadlines
• Understand and deliver on the quality expectations with an emphasis on getting it right the first time.
• Attention to detail evident in a disciplined approach
• Proven ability to work independently and in a team setting
• Ability to organize tasks, time and priorities, ability to multi-task
• Able to manage a high volume of complex studies and sites
• Flexible and adapt to off working hours in a global environment (when applicable)

Work Location Assignment: Remote
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.
Digital Transformation Strategy
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!
Equal Employment Opportunity
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 Confident
We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!
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