Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 25,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients' lives around the world.

For our client, a global pharmaceutical organization we are currently looking for a Site Activation Partner II , based in Belgium .

Role Summary

The Site Activation Partner II 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 the client's standards. Responsibility span within a country or multi-country depending on the geographical region and business needs.

Responsibilities

Clinical Trial Site Activation & Conduct

• Initiate and coordinate activities and essential documents management towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to sites initiation approval
• Register investigator sites in the client's registries and systems as required. Update and regularly maintain the registry with accuracy and have it inspection ready
• Work directly and interact with investigator sites to complete critical information and readiness for site activation; inclusive of but not limited to Investigator Initiation Packages (IIP) essential documents components, study contracts contacts, clinical supply shipment information, payment information, IRB submission and status
• Take the lead to resolve issues or concerns and timely escalation of issues where applicable
• Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572 revisions, for internal regulatory approval within required timelines
• Lead a subset and assist with the overall site activation process and coordinate operational activities to ensure timely site activation
• Take the Lead and Coordinates the compilation of the Central Investigator Review Board (IRB) package and submissions to approval of the study
• Coordinate the timely communication, documentation and responses between our 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 preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information as needed
• Initiate and coordinate activities and essential documents management with the investigator's sites (post SIV) during study conduct 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 revisions, Ethics Committee annual approvals
• Responsible for timely filing of documents to Trial Master File and other systems and assist with periodic quality review of study files for accuracy and completeness
• Accurately update and maintain clinical systems that track site compliance and performance within project timelines
• Lead or assist with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
• Supports investigator sites, and study teams in preparation for and providing responses to site audits / inspections

Communication

• Maintain ongoing contact and communication with the study team and respond promptly to study team and investigator site requests
• Attend study Start-up meeting and provide functional updates on a country and site level
• Establish tools for efficient updates to study team as needed regarding site status, issues, delays, approvals
• Disseminate Central Ethics Approval to study team and Investigator Sites
• Communicate Local sites approvals to study team members and stakeholders

Clinical Trial Site Support

• As needed, perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with study documentation is in accordance with prevailing laws, Good Clinical Practices, and the client's standards
• Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence / persistence of issues

Additional Responsibilities:

• Deep understanding of the Site Activation requirements and processes within the country and be able to develop and implement in more than one (1) country to enable multi-country coverage.
• Assigned as Site Activation Partner Point of Contact (PoC) on a study conducted in multi-country:
  • Represent the SAP role on the study
  • Take the lead in the compilation and preparation of the Investigator Initiation Package (IIP) Template for the study and share with SAP team globally
  • Communicate with SAPs globally on study information and timelines
• Be an SME on one or more system and/or process, be the go-to person and train the SAPs on these respective systems or processes
• Represent the SAP role on global initiatives
• Mentor for new hires on processes, systems and SAP activities facilitating and optimizing the time from hire/training to assignment on a study
• Able to manage a high volume of, complex studies and sites

Qualifications

• School diploma/certificate with equivalent combination of education, training and experience; BS/BA or bachelor's degree in life sciences preferred
• Minimum 6 years relevant experience in Clinical Trials environment and clinical site activation. Experience working in the pharmaceutical industry/or CRO is an asset
• Demonstrated deep knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations
• Must be fluent in Local language and in English.
• 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
• Experience working in a global environment
• Experience in working in more than 1 country is an asset

Qualifications

• School diploma/certificate with equivalent combination of education, training and experience; BS/BA or bachelor's degree in life sciences preferred
• Minimum 6 years relevant experience in Clinical Trials environment and clinical site activation. Experience working in the pharmaceutical industry/or CRO is an asset
• Demonstrated deep knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations
• Must be fluent in Local language and in English.
• 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
• Experience working in a global environment
• Experience in working in more than 1 country is an asset

Skills

• Demonstrated knowledge and understanding of key operational elements of a clinical trial and processes (e.g., study start-up, conduct, close-out activities, reporting, etc.) and ability to gain command of these processes
• 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
• Proven 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.

Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.

Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. #LI-EW1