Site Activation Partner

2 mesi fa

Rome, Italia Pfizer A tempo pieno

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 within a country and may span over more than 1 country depending on the geographical region and business needs.

JOB RESPONSIBILITIES:

Clinical Trial Site Activation

Initiate and coordinate activities and essential documents management during start-up towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for site 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, for internal regulatory approval within required timelines

Manage and coordinate with other supporting roles to ensure timely site activation and operational activities.

Collection of documents needed from sites for EU-CTR submission. 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 (SIP) 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 a high-quality documents and updates through the life cycle of a study such as the documents management for protocol amendments, and other activities required during study conduct

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 session with site personnel on Pfizer requirements and 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:

A good understanding of the Site Activation requirements and processes within the country/region and be able to learn and potentially implement in more than one (1) country

May be assigned as Site Activation Partner Point of Contact (PoC) on a study conducted in multi-country

May be assigned as an SME on a system and/or process, and represent the SAP function as applicable

May represent the SAP role on global initiatives

Able to act as an SME on projects and initiatives, as requested

Support the mentoring of new hires on processes/ systems

Systems & Tools

Ability to use and learn systems, and to use independently

Microsoft Suite

Clinical Trial Management Systems (CTMS)

Electronic Trial Master File

Electronic Investigator Site File (e.g. Florence)

Document exchange portals

Shared Investigator Platform

Ethics, National Networks and Governing Bodies Portals and platforms (as needed)

QUALIFICATIONS/SKILLS

Basic Qualifications

Bachelor's degree in a scientific or business-related discipline required; BSc in life sciences preferred

2 years relevant experience in clinical site management.

Experience working in the pharmaceutical industry/or CRO in study site activation is an asset

Knowledge of clinical trial methodologies, ICH/GCP, FDA and Globaland local country regulations

Must be fluent in Local language and in English. Multilanguage capability is an asset

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

LAST DAY TO APPLY: JULY 26th 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.

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.

Medical#LI-PFE

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