Site Activation Specialist

3 weeks ago

Delhi, Delhi, India Lifelancer Full time

About the Role

The Site Activation Partner is responsible for leading or supporting operational activities from startup to closeout for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and Pfizer standards. This role may span over more than one country depending on the geographical region and business needs.

Key Responsibilities

  • Clinical Trial Site Activation: Initiate and coordinate activities and essential documents management during startup 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, FDA 1572/Attestation Form for internal regulatory approval within required timelines.
  • Manage and coordinate with other supporting roles to ensure timely site activation and operational activities.
  • Support the compilation of the Central Investigator Review Board (IRB) package and submissions to approval of the study (where applicable) and other committees as per country requirements.
  • Coordinate the timely communication, documentation, and responses between Pfizer and Central Ethics committee to bring clinical study to approval (country dependent).
  • Support investigators sites with local IRB workflow from preparation, submission, through approval.
  • 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 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 investigators 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, FDA 1572/Attestation revisions, Ethics Committee annual approvals, and other activities required during study conduct.
  • Ensure maintenance of IRB/Ethics and other committees activities as applicable.
  • 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 sessions 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 multicountry.
  • 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:
    • BS/BA or bachelors degree in Life Sciences preferred.
    • 26 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 Global and local country regulations.
    • Must be fluent in Local language and in English. Multilanguage capability is an asset.
    • For individuals based in Canada: Bilingualism (French English) 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.

Physical/Mental Requirements:

  • Demonstrated knowledge of clinical research and development processes, Key operational elements of a clinical trial, and ability to gain command of process details.
  • 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.
  • Ability to work independently and also as a team member.
  • Ability to organize tasks, time, and priorities, ability to multitask.
  • Understand basic medical terminology, GCP requirements, and proficient in computer operations.

Organizational Relationships:

  • Global Study Manager and StartUp Project Manager Global Study Clinician.
  • Local Site Relationship Partners and Director Clinical Site Operations Clinical Trials Manager and other Local Roles.
  • Global Investigator Initiation Package (IIP) Regulatory Group.
  • Local Regulatory Manager CTA Hub and CTA Submission Managers.
  • Site Intelligence Team.
  • Contract specialists.
  • Investigators Sites.
  • Country Ethics Committee representatives.
  • Other governing bodies representatives.
  • Local provincial/States and national networks.

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