[Hiring] Site Activation Partner @Parexel

Role Description

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Key Accountabilities

• 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, Institutional Review Board (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 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 client 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 and 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, 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 (TMF) 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.
• 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 client requirements and to ensure ongoing compliance with study documentation in accordance with prevailing laws, Good Clinical Practices, and client 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.
• Subject Matter Expert (SME):
  • 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 country.
  • May be assigned as Site Activation Partner Point of Contact (PoC) on a study conducted in multiple countries.
  • 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.
• Compliance with Parexel standards:
  • Complies with required training curriculum.
  • Completes timesheets accurately as required.
  • Submits expense reports as required.
  • Updates CV as required.
  • Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements.

Qualifications

• 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.
• 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 multi-task.
• Understand basic medical terminology, GCP requirements and proficient in computer operations.
• Ability to use and learn systems, and to use independently.
• Flexible and adapt to off working hours in a global environment (when applicable).
• Able to travel as needed, including some international travel possible.

Requirements

• Minimum 2 years' relevant experience in clinical site management.
• Experience working in the pharmaceutical industry/or CRO in study site activation preferred.
• 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 preferred.
• Individuals based in Canada: Bilingualism (French, English) is preferred.
• 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.

Education

• School diploma or certificate with equivalent combination of education, training and experience or
• Bachelor of Science or Bachelor of Arts or equivalent.
• Education in life sciences discipline is preferred.