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SITE ACTIVATION PARTNER II (Site Start

Pfizer
Warsaw, IN 46580
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**ROLE SUMMARY**



The Site Activation Partner is 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.



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



**Clinical Trial Site Activation**



+ Take the Lead, initiate 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

+ Support investigators sites with local IRB workflow from preparation, submission through approval

+ Collaborate with in country regulatory group, and other stakeholders and provide related/applicable site documents as applicable

+ Coordinate 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.

+ Collaborate with the Study Team on the development and readiness of sites eISF when utilized

+ Support & implement activities in Shared Investigator Platform to align with Pfizer strategy

+ Coordinate translation of documents that are within scope with the preferred translation 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, reapprovals 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:**



+ Be a Subject Matter Expert on one or more system and/or process

+ Represent the SAP role on global initiatives



**BASIC QUALIFICATIONS**



+ School diploma/certificate with equivalent combination of education, training and experience; BS/BA or bachelor's degree in life sciences preferred

+ Minimum 3 years 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 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 e.g CTMS, Network portals, SIP etc..

+ Experience working in a global environment

+ Experience in working in more than 1 country is an asset



**PHYSICAL/MENTAL REQUIREMENTS**



+ Ability to work under pressure to meet deadlines

+ Understand the quality expectations and emphasis on right first time.

+ 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

+ Able to manage a high volume of, complex studies and sites

+ Flexible and adapt to off working hours in a global environment (when applicable)



\#LI-PFE



Purpose



**Breakthroughs that change patients' lives** ... At Pfizer we are apatient 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 iscommitted to celebratingthis,in all itsforms - 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.



Medical



\#LI-PFE
Posted: 2021-06-11 Expires: 2021-07-12
Sponsored by:
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SITE ACTIVATION PARTNER II (Site Start

Pfizer
Warsaw, IN 46580

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