Site Activation Specialist
On behalf of our client, a leading international pharmaceutical company, Swisslinx is looking for a Site Activation Specialist. If this is you, you will be responsible for start-up activities for the assigned studies within Clinical Operations.
Contract type - 12 months (extension likely)
Start Date - August to September
Location - Rotkreuz, near Zug
Workload - 100%
Work type - hybrid possible (2-3 days campus)
Your mission:
â?¢ Responsible for the effective operations and delivery of site activation deliverables across all regions, within the assigned projects
â?¢ Supports the pre-study site identification/selection process for relevant studies through collection and analysis of site feasibility information
â?¢ Maintain regular communications with investigational sites/CRO to ensure timely completion of the required site activation activities/documentation and resolve or escalate issues in a timely manner
â?¢ Collect, receive and perform the first review of required study-specific site regulatory/essential documents in accordance with applicable SPs, guidelines,and study timelines and requirements
â?¢ Coordinate Investigator Review Board (IRB)/Ethics Committee (EC)/other relevant regulatory submissions in collaboration with sites/study teams
â?¢ Work with sites to ensure informed consent form meets the required regulatory and company requirements
â?¢ Facilitate the translation of essential documents that may be required in languages other than English for the purposes of submission to and approval from Competent Authorities and/or IRB/EC
â?¢ Coordinate the clinical trial insurance process to ensure timely results and support throughout the conduct of the clinical study
â?¢ Support contract and budget negotiations in partnership with Contracting and Study Teams
â?¢ Ensure Purchase orders and Fair Market Value assessments are completed for timely start-start up
â?¢ Support study instrument placements, Obtain import/export licensure
â?¢ Support implementation and use of eTools at the site
â?¢ Collect and maintain relevant country, local, state, and site-level regulatory intelligence for future use
â?¢ Work closely with Study Teams to deliver study start-up tasks
â?¢ Solve identified issues with appropriate timely escalation to the Study Teams
â?¢ Support internal audit and external inspection activities; contribute to CAPAs as required
â?¢ May be responsible for other responsibilities as assigned
Your background:
â?¢ The perfect candidate has a degree in life sciences and more than 3 years of experience in a relevant field. The person is experienced in study start-up and has knowledge of global and local regulatory requirements. Additionally, the candidate is flexible in working hours to support multi-national team members. Lastly, the candidate is fluent in English.
â?¢ Min. 3 years experience in clinical trial planning, including IRB/Ethics Committee, Competent authority submissions and contracts (MANDATORY)
â?¢ Experience in study start-up is required (MANDATORY)
â?¢ Working knowledge of global and local regulatory requirements (IVDR and other applicable regulations) (MANDATORY)
â?¢ Required to support multi-national team members, and flexibility in working hours may be needed (MANDATORY)
â?¢ Associate or Bachelorâ??s degree in chemistry, biology, other life sciences, or a related field, or equivalent combination of education and experience (MANDATORY)
â?¢ Strong stakeholder management skills, to work closely with Contracting, Legal, Privacy, Study Teams, CRO, and Sites.
â?¢ Knowledge of clinical trial methodologies, medical terminology, ICH/GCP
â?¢ Ability to organize tasks, time, and priorities, ability to multi-task
â?¢ Participate and work effectively with multiple cross-functional teams
â?¢ Must be fluent in English, and any additional language is a plus
What's on offer
â?¢ An initially 12 month contract, with likely extension, at an internationally-renowned pharmaceutical company.
â?¢ A competitive salary.
â?¢ A flexible hybrid working policy.
If this sounds like you, donâ??t hesitate to apply here or reach out directly to Hugo Palejowski, Recruiter: Write an email.
Contract type - 12 months (extension likely)
Start Date - August to September
Location - Rotkreuz, near Zug
Workload - 100%
Work type - hybrid possible (2-3 days campus)
Your mission:
â?¢ Responsible for the effective operations and delivery of site activation deliverables across all regions, within the assigned projects
â?¢ Supports the pre-study site identification/selection process for relevant studies through collection and analysis of site feasibility information
â?¢ Maintain regular communications with investigational sites/CRO to ensure timely completion of the required site activation activities/documentation and resolve or escalate issues in a timely manner
â?¢ Collect, receive and perform the first review of required study-specific site regulatory/essential documents in accordance with applicable SPs, guidelines,and study timelines and requirements
â?¢ Coordinate Investigator Review Board (IRB)/Ethics Committee (EC)/other relevant regulatory submissions in collaboration with sites/study teams
â?¢ Work with sites to ensure informed consent form meets the required regulatory and company requirements
â?¢ Facilitate the translation of essential documents that may be required in languages other than English for the purposes of submission to and approval from Competent Authorities and/or IRB/EC
â?¢ Coordinate the clinical trial insurance process to ensure timely results and support throughout the conduct of the clinical study
â?¢ Support contract and budget negotiations in partnership with Contracting and Study Teams
â?¢ Ensure Purchase orders and Fair Market Value assessments are completed for timely start-start up
â?¢ Support study instrument placements, Obtain import/export licensure
â?¢ Support implementation and use of eTools at the site
â?¢ Collect and maintain relevant country, local, state, and site-level regulatory intelligence for future use
â?¢ Work closely with Study Teams to deliver study start-up tasks
â?¢ Solve identified issues with appropriate timely escalation to the Study Teams
â?¢ Support internal audit and external inspection activities; contribute to CAPAs as required
â?¢ May be responsible for other responsibilities as assigned
Your background:
â?¢ The perfect candidate has a degree in life sciences and more than 3 years of experience in a relevant field. The person is experienced in study start-up and has knowledge of global and local regulatory requirements. Additionally, the candidate is flexible in working hours to support multi-national team members. Lastly, the candidate is fluent in English.
â?¢ Min. 3 years experience in clinical trial planning, including IRB/Ethics Committee, Competent authority submissions and contracts (MANDATORY)
â?¢ Experience in study start-up is required (MANDATORY)
â?¢ Working knowledge of global and local regulatory requirements (IVDR and other applicable regulations) (MANDATORY)
â?¢ Required to support multi-national team members, and flexibility in working hours may be needed (MANDATORY)
â?¢ Associate or Bachelorâ??s degree in chemistry, biology, other life sciences, or a related field, or equivalent combination of education and experience (MANDATORY)
â?¢ Strong stakeholder management skills, to work closely with Contracting, Legal, Privacy, Study Teams, CRO, and Sites.
â?¢ Knowledge of clinical trial methodologies, medical terminology, ICH/GCP
â?¢ Ability to organize tasks, time, and priorities, ability to multi-task
â?¢ Participate and work effectively with multiple cross-functional teams
â?¢ Must be fluent in English, and any additional language is a plus
What's on offer
â?¢ An initially 12 month contract, with likely extension, at an internationally-renowned pharmaceutical company.
â?¢ A competitive salary.
â?¢ A flexible hybrid working policy.
If this sounds like you, donâ??t hesitate to apply here or reach out directly to Hugo Palejowski, Recruiter: Write an email.
À propos de l'entreprise
