Site Activation Partner

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 (COMPANY NAME) 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 (COMPANY NAME) 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 (COMPANY NAME) requirements and to ensure ongoing compliance with study documentation in accordance with prevailing laws, Good Clinical Practices, and (COMPANY NAME) 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
• Minimum 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 Global and 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

PHYSICAL/MENTAL REQUIREMENTS
- Demonstrated knowledge of clinical research and development processes, Key operational ele