Syneos Health

Site Activation Partner, homebased in Netherlands

3 days left

Location
Home Based, NLD
Salary
Competitive
Posted
18 May 2021
Closes
17 Jun 2021
Ref
21006254
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. 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 In this role you will be working homebased in Netherlands.

The Site Activation Partner is responsible for supporting operational activities related to site evaluation, activation, initiation, monitoring and close out for assigned investigator sites/studies to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and the client's standards. The Site Activation Partner will provide technical and logistical support to the Site Relationship Partners to deliver Investigator Initiation and Study Start Up.

Clinical Trial Site Activation & Conduct
  • Assist with study site activation activities to ensure timely site activation.
  • Register investigator sites in the client's registries as required.
  • Support and/or coordinate central Investigator Review Board (IRB) submissions when needed.
  • Work with investigator sites to complete critical information for site activation; inclusive of, but not limited to, Investigator Initiation Packages (IIP), confidentiality agreements, study contracts, clinical supply shipment information, payment information, IRB submission and status.
  • Support local IRB workflow from submission through approval and support reporting of updates to safety information.
  • Follow-up with investigator sites on status of study documentation and resolve or escalate issues in a timely manner.
  • Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572 revisions, for internal regulatory approval within required timelines.
  • Communicate site approvals to the Site Relationship Partners, Study Start Up Project Managers (where applicable) and relevant study team members.
  • Assist with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information as needed.
  • Work with investigator sites throughout the study to complete required ongoing study documents such as documents for protocol amendments and FDA 1572 revisions.
  • Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
  • Submit within required timeframes all needed documentation, updates and tracking including, but not limited to, Trial Master File documentation, site activation status, protocol amendment status.
  • Problem solve identified issues with appropriate timely escalation to the Site Relationship Partner.
  • Assist the Site Relationship Partner with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
  • Support investigator sites, Site Relationship Partners, Study Managers and study teams in preparation for and providing responses to site audits/inspections.


Communication
  • Act as a point contact for the GSSO team members for designated project site communications, correspondence and associated documentation.
  • Maintain ongoing contact and communication with the GSSO team members as needed.
  • Respond promptly to GSSO team member and investigator site requests.
  • Establish tools for efficient updates to the GSSO Study Team members as needed regarding site status, issues, delays, and approvals.


Clinical Trial Monitoring Support

  • As needed, support the Site Relationship Partner with 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.
  • In collaboration with the Site Relationship Partner, conduct or oversee investigator site activation activities, IIP completion, site budget and contract negotiation, and ensure timely management of emerging issues that may compromise time to site activation.
  • In collaboration with Site Relationship Partner and Outsourcing Lead, facilitate site payments as needed and as per contracts and work with the appropriate groups to resolve issues.
  • In support of Site Relationship Partner, conduct remote monitoring activities, with a focus on Trial Master File/Site Master File reconciliation, investigational product reconciliation or other technical or logistical supportive activities that facilitate inspection readiness.
  • Identify and resolve in collaboration with Site Relationship Partner 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.
  • Assist to resolve data queries within required timelines; support database release as needed for supported sites/functions.
The ideal candidate has:

Qualifications
  • School diploma/certificate or equivalent combination of education, training and experience; BS/BA or Bachelor's degree in life sciences preferred. In general, candidates for this job would hold the following levels of education/experience:
    • 2 years relevant experience in clinical site management
    • Experience in study activation and site management is an asset
    • Knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations
    • Must be fluent in English, and the regulatory language of the appointed location

Skills
  • Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
  • Demonstrated knowledge of global and local regulatory requirements
  • Demonstrated understanding of key operational elements of a clinical trial (e.g., study start-up, conduct, close-out activities, reporting, etc.)
  • 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 to document review, adherence to SOPs, metrics, etc.
  • 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.
  • Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
  • Required to support multi-national team members, and flexibility in working hours may be needed occasionally


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.

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