Clinical Site Activation Specialist

4 settimane fa

Roma, Lazio, Italia Pfizer A tempo pieno

JOB SUMMARY:

The Clinical Site Activation Specialist plays a pivotal role in overseeing and facilitating operational tasks from initiation to conclusion for designated studies and investigator locations. This position ensures adherence to study timelines while complying with relevant regulations, Good Clinical Practices, and Pfizer's internal standards. Responsibilities may extend across multiple countries based on regional and business requirements.

KEY RESPONSIBILITIES:

Clinical Trial Site Activation

  • Lead and manage activities related to essential document oversight during the start-up phase, culminating in the creation of a comprehensive Investigator Initiation Package (IIP) for site approval.
  • Provide assistance in addressing challenges or concerns, ensuring timely escalation of site-related issues when necessary.
  • Prepare, verify, and submit regulatory documentation, including completed IIPs and IRB approval forms, for internal regulatory clearance within stipulated timelines.
  • Coordinate with various supporting roles to guarantee prompt site activation and operational execution.
  • Gather necessary documentation from sites for EU-CTR submissions and assist in the preparation, management, and distribution of clinical documents and reports in line with established protocols.
  • Support and implement initiatives within the Shared Investigator Platform (SIP) to align with Pfizer's strategic objectives.

Clinical Trials Execution

  • Post-activation, initiate and coordinate essential document management with investigator sites, ensuring high-quality documentation and updates throughout the study lifecycle, including protocol amendments.
  • Ensure timely filing of documents in the Trial Master File and assist in periodic quality assessments of study files for accuracy and completeness.
  • Maintain and update clinical trial systems that monitor site compliance and performance against project timelines.
  • Assist investigator sites and study teams in preparing for and responding to site audits and inspections.

Internal & External Communication

  • Maintain regular communication with the study team, promptly addressing requests from both the study team and investigator sites.
  • Provide functional updates at both country and site levels as required.
  • Establish efficient communication tools to keep the study team informed about site status, issues, delays, and approvals.
  • Disseminate Central or Local Ethics Approval to the study team and investigator sites as applicable.
  • Communicate local site approvals to study team members and stakeholders.

Clinical Trial Site Support

  • Conduct awareness sessions with site personnel on Pfizer's requirements to ensure ongoing compliance with study documentation in accordance with applicable laws and Good Clinical Practices.
  • Identify and resolve issues at investigator sites within required timeframes, collaborating with the study team and local colleagues on corrective and preventive actions.

Additional Responsibilities:

  • Possess a solid understanding of site activation requirements and processes within the region, with the potential to learn and implement across multiple countries.
  • May serve as the Site Activation Partner Point of Contact (PoC) for studies conducted across multiple countries.
  • May act as a Subject Matter Expert (SME) on specific systems or processes, representing the Site Activation Partner function as needed.
  • May represent the Site Activation Partner role in global initiatives.
  • Support the mentoring of new hires on processes and systems.

Systems & Tools:

Proficient in utilizing and learning various systems independently, including:

  • 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 field is required; a BSc in life sciences is preferred.
  • A minimum of 2 years of relevant experience in clinical site management.
  • Experience in the pharmaceutical industry or CRO in study site activation is advantageous.
  • Familiarity with clinical trial methodologies, ICH/GCP, FDA, and local regulations.
  • Fluency in the local language and English is essential; multilingual capabilities are a plus.
  • Strong verbal and written communication skills for effective interaction with colleagues and stakeholders.
  • Good technical skills with the ability to learn and navigate multiple systems.

Purpose:

Breakthroughs that change patients' lives ... At Pfizer, we are a patient-centric organization, guided by our core values: courage, joy, equity, and excellence. Our culture of innovation drives our commitment to transforming millions of lives.

Digital Transformation Strategy:

We are advancing our mission through a comprehensive digital transformation strategy, adopting new data, modeling, and automated solutions to enhance drug discovery and development, ultimately improving health outcomes and patient experiences.

Flexibility:

We strive to foster a trusting and flexible workplace culture that promotes work-life harmony, attracts talent, and empowers everyone to perform at their best.

Equal Employment Opportunity:

We believe that a diverse and inclusive workforce is vital for our success. Pfizer is committed to celebrating diversity in all its forms, allowing us to reflect the communities and patients we serve. Together, we continue to cultivate a culture that encourages, supports, and empowers our employees.

  • Clinical Site Activation Specialist

    6 giorni fa

    Roma, Lazio, Italia Pfizer A tempo pieno

    JOB SUMMARY: The Clinical Site Activation Specialist plays a pivotal role in overseeing and facilitating operational tasks from initiation to conclusion for designated studies and investigator locations. This position ensures adherence to study timelines while complying with relevant regulations, Good Clinical Practices, and Pfizer's internal standards....

  • Clinical Site Activation Specialist

    2 settimane fa

    Roma, Lazio, Italia Pfizer A tempo pieno

    JOB SUMMARY: The Clinical Site Activation Specialist plays a pivotal role in overseeing and facilitating operational tasks from initiation to conclusion for designated studies and investigator locations. This position ensures adherence to study timelines while complying with relevant regulations, Good Clinical Practices, and Pfizer's internal standards....

  • Clinical Site Activation Specialist

    1 settimana fa

    Roma, Lazio, Italia Pfizer A tempo pieno

    JOB SUMMARY: The Clinical Trial Activation Lead is tasked with overseeing or assisting operational functions from initiation to completion for designated studies and investigator locations, ensuring adherence to study schedules and compliance with applicable regulations, Good Clinical Practices, and Pfizer's standards. Responsibilities may extend across...

  • Clinical Research Associate

    3 giorni fa

    Roma, Lazio, Italia Thermo Fisher Scientific A tempo pieno

    Job Summary:We are seeking a highly skilled Clinical Research Associate to join our team at Thermo Fisher Scientific. As a Clinical Research Associate, you will be responsible for ensuring the integrity and quality of clinical trials.Key Responsibilities:Conduct on-site visits to monitor clinical trials and ensure compliance with regulatory...

  • Clinical Research Associate II

    1 settimana fa

    Roma, Lazio, Italia Allergan A tempo pieno

    Job SummaryWe are seeking a highly skilled Clinical Research Associate II to join our team at Allergan. As a Clinical Research Associate II, you will be responsible for ensuring the successful execution of clinical studies at investigative sites.Key ResponsibilitiesStudy Site Monitoring: Monitor activities conducted by clinical investigative sites to ensure...

  • Clinical Research Associate

    6 giorni fa

    Roma, Lazio, Italia Tn Italy A tempo pieno

    Job Summary:Tn Italy is seeking a highly skilled Clinical Research Associate to join our team. As a Clinical Research Associate, you will be responsible for monitoring and managing clinical trials, ensuring compliance with study protocols, regulations, and timelines.Key Responsibilities:Conduct site qualification, initiation, monitoring, and closeout visits...

  • Clinical Research Associate

    6 giorni fa

    Roma, Lazio, Italia Tn Italy A tempo pieno

    Job Summary:Tn Italy is seeking a highly skilled Clinical Research Associate to join our team. As a Clinical Research Associate, you will be responsible for monitoring and managing clinical trials, ensuring compliance with study protocols, regulations, and timelines.Key Responsibilities:Conduct site qualification, initiation, monitoring, and closeout visits...

  • Clinical Trial Operations Manager

    1 settimana fa

    Roma, Lazio, Italia Johnson & Johnson A tempo pieno

    Job Summary:We are seeking a highly skilled Clinical Trial Operations Manager to join our team at Johnson & Johnson. As a key member of our clinical operations team, you will be responsible for managing local trial activities and project planning to meet site open and recruitment targets, while ensuring high-quality data is delivered on time and within study...

  • Clinical Quality Assurance Manager

    2 giorni fa

    Roma, Lazio, Italia Proclinical Group A tempo pieno

    Job DescriptionProclinical Group is seeking a dedicated Clinical Quality Assurance Manager to join our team. This role is crucial in ensuring that clinical trials and studies are conducted to the highest quality standards, in compliance with international standards, legislation, protocols, and company processes.Key Responsibilities:Quality Management System...

  • Clinical Research Associate II

    6 giorni fa

    Roma, Lazio, Italia Allergan A tempo pieno

    Job SummaryWe are seeking a highly skilled Clinical Research Associate II to join our team at Allergan. As a key member of our site monitoring and management team, you will be responsible for ensuring the successful execution of clinical studies at investigative sites.Key Responsibilities:Study Site Monitoring: Conduct site qualification, initiation, interim...

  • Clinical Research Associate II

    7 giorni fa

    Roma, Lazio, Italia Allergan A tempo pieno

    Job SummaryWe are seeking a highly skilled Clinical Research Associate II to join our team at Allergan. As a key member of our site monitoring and management team, you will be responsible for ensuring the successful execution of clinical studies at investigative sites.Key Responsibilities:Study Site Monitoring: Conduct site qualification, initiation, interim...

  • Director of Clinical Operations

    6 giorni fa

    Roma, Lazio, Italia Merck KGaA, Darmstadt, Germany A tempo pieno

    Job SummaryWe are seeking a highly experienced and skilled Director of Clinical Operations to lead our clinical study operations in Italy. As a key member of our team, you will be responsible for providing strategic direction and oversight to ensure the successful execution of clinical trials.Key ResponsibilitiesProvide leadership and direction to clinical...

  • Director of Clinical Operations

    7 giorni fa

    Roma, Lazio, Italia Merck KGaA, Darmstadt, Germany A tempo pieno

    Job SummaryWe are seeking a highly experienced and skilled Director of Clinical Operations to lead our clinical study operations in Italy. As a key member of our team, you will be responsible for providing strategic direction and oversight to ensure the successful execution of clinical trials.Key ResponsibilitiesProvide leadership and direction to clinical...

  • Clinical Application Specialist IGT-D

    1 mese fa

    Roma, Lazio, Italia Philips A tempo pieno

    Job TitleClinical Application Specialist IGT-D - Center ItalyJob DescriptionClinical Application specialist:Promoting Philips IGT-D products and drive disposable utilization through clinical education and cath-lab support in the assigned territory in Center Italy. Your role:Providing primary training and education to customers.Disseminating technical product...

  • Clinical Operations Manager Lead

    6 giorni fa

    Roma, Lazio, Italia Merck Sharp & Dohme (Msd) A tempo pieno

    Job SummaryMerck Sharp & Dohme (Msd) is seeking a highly skilled Clinical Operations Manager Lead to join our team. This role is accountable for the execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country regulations, our company policies and procedures, and with quality standards, both internally and...

  • Clinical Operations Manager Lead

    7 giorni fa

    Roma, Lazio, Italia Merck Sharp & Dohme (Msd) A tempo pieno

    Job SummaryMerck Sharp & Dohme (Msd) is seeking a highly skilled Clinical Operations Manager Lead to join our team. This role is accountable for the execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country regulations, our company policies and procedures, and with quality standards, both internally and...

  • Lead Clinical Data Management Specialist

    6 giorni fa

    Roma, Lazio, Italia MAI Fortrea Development Limited A tempo pieno

    About MAI Fortrea Development Limited As a prominent global contract research organization (CRO) dedicated to scientific excellence and extensive clinical development expertise, MAI Fortrea Development Limited offers pharmaceutical, biotechnology, and medical device clients a comprehensive suite of clinical development, patient access, and technological...

  • Lead Clinical Data Management Specialist

    6 giorni fa

    Roma, Lazio, Italia MAI Fortrea Development Limited A tempo pieno

    About MAI Fortrea Development Limited As a prominent global contract research organization (CRO) dedicated to scientific excellence and with extensive experience in clinical development, MAI Fortrea Development Limited offers pharmaceutical, biotechnology, and medical device clients a comprehensive suite of clinical development, patient access, and...

  • Lead Clinical Data Management Specialist

    7 giorni fa

    Roma, Lazio, Italia MAI Fortrea Development Limited A tempo pieno

    About MAI Fortrea Development Limited As a prominent global contract research organization (CRO) dedicated to scientific excellence and with extensive experience in clinical development, MAI Fortrea Development Limited offers pharmaceutical, biotechnology, and medical device clients a comprehensive suite of clinical development, patient access, and...

  • Lead Clinical Data Management Specialist

    7 giorni fa

    Roma, Lazio, Italia MAI Fortrea Development Limited A tempo pieno

    About MAI Fortrea Development Limited As a prominent global contract research organization (CRO) dedicated to scientific excellence and extensive clinical development expertise, MAI Fortrea Development Limited offers pharmaceutical, biotechnology, and medical device clients a comprehensive suite of clinical development, patient access, and technological...