Freelance SSUA II, Sr. SSUA

Study Start Up Paris, France


Description

Position at Premier Research

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.

We’re looking for an exceptional Freelance Senior Site Start-Up Associate to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.

At Premier Research, we are science-minded and heart-centered. Join us.

The Freelance Senior Site Start-Up Associate performs country specific tasks associated with the start-up of a clinical trial in accordance with all applicable regulations, standards, and study-specific requirements. This includes but is not limited to the following tasks: liaises with the Site Recruitment Associate or Lead, as applicable, to provide site feasibility updates as well as study start-up metrics and site contact information for the site activation, coordinate with the Clinical Research Associate to disseminate the Investigator Site File binders, performs essential document collection and review, status tracking, site communications, Informed Consent review, Ethics Committees (ECs) /Institutional Review Board (IRB) and Regulatory Authorities (RAs) submissions and communications, protocol and other documents amendment management, submissions and follow-up to the appropriate governing authorities on a per country basis, site contract preparation and follow-up (ROW), customs clearance and import/export license management and in general all needed preparations for site activation, within scope of the study a Sr. SSUA may be assigned to one or more start-up projects. A Sr. SSUA may work in conjunction with or under the supervision of a more senior level SSUA.

  • Takes responsibility for quality deliverables at the country level for study start-up.
  • Follows project requirements and applicable country rules.
  • Proactively forecasts submission/approval timelines and ensures they are adhered to.
    If forecasted timelines are not reached, provides clear rationale for delays, provides contingency plan to mitigate impact, and escalates the issue as soon as identified.- May serve as the primary point of contact for the Project Manager, Clinical Manager, Regulatory Start-up Manager (or designee) during start-up on allocated projects.
  • Prepares and submits Central EC/IRB Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required.  Prepares ongoing submissions, amendments, and periodic notifications (including safety reporting) required by central and local EC and RA, and other local regulatory authorities as needed within the country, as required by local rules.. Submits end of study notifications to RAs, ECs IRBs and other local authorities in the specified country according to national timelines.
  • Performs and/or oversight of essential document collection and review, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines.
  • Local Investigator Contract and budget negotiator (where applicable) produces site-specific contracts from country template.  Submits proposed contract and budget to the site for review.  Negotiates budget and contract with site and via Contracts Lead with Sponsor until resolution of issues and contract execution.
  • SSUA (where applicable) - conducts the site identification/feasibility process on a country level by contacting sites to confirm the investigator’s interest and eligibility to participate in a clinical trial protocol. Helps Medical Information team with site outreach for pre-award assessments as needed and develops and maintains operational relationships with key sites and networks.
  • Prepares and/or oversight of checklist for Investigational Product (IP) release according to country regulations.
  • Ensures oversight accuracy and completeness of Trial Master File documents submitted by Site Start-up Associate throughout the study and performs a QC review of files for which Start-up Associate is acting as document owner, in line with the requirements set in the File Management Plan.
  • Provides and/or oversight of all regulatory documents and relevant study correspondence along with translations to the Clinical Research Associate throughout the study conduct. Collects and/or oversight of information on submission deadlines and timeline metrics for RA, ECs/IRBs and other local bodies as appropriate.
  • Liaises with internal team members to review areas that impact study start-up and shares start-up information with the project team.
  • Provides country-level intelligence on site start-up. Ensures that local country regulatory intelligence is maintained on the central repository, e.g. RA submissions, EC/IRB submissions, notifications to data protection authorities, notifications/applications to any other local/federal/national body, and import/ export license applications where these are obtained with RA applications.
  • Sets up and maintains a country folder with country ECs/IRBs and local authority addresses and requirements.
  • The SSUA may set up and maintain details of existing site and institution contract requirements, as well as the necessary templates and fees, on the Global Study Start-Up portal on SharePoint.
  • Provides quality review of the informed consent and adapts the template as appropriate, as well as other patient documents, or specific documentation that is required in the country.
  • Works within the scope of Regulatory Start Up plan (RSSP), study processes, applicable regulations, ICH-GCP and/or ISO14155 and any other requirements mandated by the study.
  • May provide regular updates of country specific information on the Global Study Start-Up portal on SharePoint.
  • Ensures documentation of QC of eTMF within the scope of File management Plan (FMP) from the Study Start-Up phase or other sections where the Start-up Associate is acting as document owner as the final deliverable to the client.
  • May support preparation of specific start-up strategy for projects at the proposal stage to support business development opportunities.
  • Provides training for local affiliate employees and other applicable internal teams for changes in country specific regulations for clinical trials.
  • Reviews and advises on Regulatory and Clinical Operations SOPs, WGs and ADs related to Study Start-Up and regulatory tasks or country specific pharmacovigilance reporting requirements.
  • Performs other duties as required.
  • Serves as primary liaison for site start-up and site start-up management issues, escalating to RSM, CM and/or PM as required.
  • Ensures that all site start-up tasks meet expectations and are delivered in accordance with the contracted timelines.
  • Identifies, monitors, documents, and tracks out-of-scope activities.
  • Interacts with site, clients, vendors and other functional areas as secondary project contact for site issues and questions.
  • Ability to work accurately, within quality expectations and agreed timelines.
  • Ability to interpret the relevant directives and guidelines.
  • May serve as an Independent Essential Document Reviewer and/or perform second pass review of Essential Documents.
  • Assists with coaching, mentoring, supervising and training staff on the SSUA role.
  • Participates in corporate initiatives and actions that ensure the continued success of the company.
  • High efficiency: Completing the assigned tasks within minimum hours.
  • Is able to drive process improvement initiatives across the department and the organization that impact a more efficient and effective Start-up and Regulatory procedures.
  • Participates in Client and/or internal Kick off meetings (KOM).
  • Participates in BDM in person or via phone, as required.
  • Possible Travel 10%
  • Takes responsibility for quality deliverables at the country level for study start-up.
  • Follows project requirements and applicable country rules.
  • Proactively forecasts submission/approval timelines and ensures they are adhered to.
    If forecasted timelines are not reached, provides clear rationale for delays, provides contingency plan to mitigate impact, and escalates the issue as soon as identified.- May serve as the primary point of contact for the Project Manager, Clinical Manager, Regulatory Start-up Manager (or designee) during start-up on allocated projects.
  • Prepares and submits Central EC/IRB Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required.  Prepares ongoing submissions, amendments, and periodic notifications (including safety reporting) required by central and local EC and RA, and other local regulatory authorities as needed within the country, as required by local rules.. Submits end of study notifications to RAs, ECs IRBs and other local authorities in the specified country according to national timelines.
  • Performs and/or oversight of essential document collection and review, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines.
  • Local Investigator Contract and budget negotiator (where applicable) produces site-specific contracts from country template.  Submits proposed contract and budget to the site for review.  Negotiates budget and contract with site and via Contracts Lead with Sponsor until resolution of issues and contract execution.
  • SSUA (where applicable) - conducts the site identification/feasibility process on a country level by contacting sites to confirm the investigator’s interest and eligibility to participate in a clinical trial protocol. Helps Medical Information team with site outreach for pre-award assessments as needed and develops and maintains operational relationships with key sites and networks.
  • Prepares and/or oversight of checklist for Investigational Product (IP) release according to country regulations.
  • Ensures oversight accuracy and completeness of Trial Master File documents submitted by Site Start-up Associate throughout the study and performs a QC review of files for which Start-up Associate is acting as document owner, in line with the requirements set in the File Management Plan.
  • Provides and/or oversight of all regulatory documents and relevant study correspondence along with translations to the Clinical Research Associate throughout the study conduct. Collects and/or oversight of information on submission deadlines and timeline metrics for RA, ECs/IRBs and other local bodies as appropriate.
  • Liaises with internal team members to review areas that impact study start-up and shares start-up information with the project team.
  • Provides country-level intelligence on site start-up. Ensures that local country regulatory intelligence is maintained on the central repository, e.g. RA submissions, EC/IRB submissions, notifications to data protection authorities, notifications/applications to any other local/federal/national body, and import/ export license applications where these are obtained with RA applications.
  • Sets up and maintains a country folder with country ECs/IRBs and local authority addresses and requirements.
  • The SSUA may set up and maintain details of existing site and institution contract requirements, as well as the necessary templates and fees, on the Global Study Start-Up portal on SharePoint.
  • Provides quality review of the informed consent and adapts the template as appropriate, as well as other patient documents, or specific documentation that is required in the country.
  • Works within the scope of Regulatory Start Up plan (RSSP), study processes, applicable regulations, ICH-GCP and/or ISO14155 and any other requirements mandated by the study.
  • May provide regular updates of country specific information on the Global Study Start-Up portal on SharePoint.
  • Ensures documentation of QC of eTMF within the scope of File management Plan (FMP) from the Study Start-Up phase or other sections where the Start-up Associate is acting as document owner as the final deliverable to the client.
  • May support preparation of specific start-up strategy for projects at the proposal stage to support business development opportunities.
  • Provides training for local affiliate employees and other applicable internal teams for changes in country specific regulations for clinical trials.
  • Reviews and advises on Regulatory and Clinical Operations SOPs, WGs and ADs related to Study Start-Up and regulatory tasks or country specific pharmacovigilance reporting requirements.
  • Performs other duties as required.

You'll Need:

  • Undergraduate degree or its international equivalent in a clinical, science, or health related field from an accredited institution or a licensed healthcare professional
  • Successful experience and results at SSUA Level 2Minimum of 7 years professional experience, including at least 5 years’ experience as SSUA or in submission of clinical trial applications.
  • Thorough knowledge of FDA Guidance Documents / EU Directives/Regulations / Local Regulations / ISO14155 regulations, drug / device development, and clinical monitoring procedures.
  • Thorough knowledge of ICH/GCP and/or ISO14155 and local regulatory authority drug research and development regulations required.
  • Thorough knowledge of the relevant country specific regulatory requirements for conducting clinical trials.
  • Thorough knowledge of site and institution specific contract requirements
  • Thorough knowledge of web-based communication tools for conferences and any other IT systems required for the job.
  • Thorough knowledge of national/local health systems as well as knowledge of cultural/professional practices appropriate to the country/region where the site Start-Up activities will be carried out.
  • Broader experience working on different study types/phases such as interventional IMP studies, non-interventional studies, medical Device studies, GMO studies, observational studies…Expert in the development and review of Informed Consent Form templates, other patient documents, or specific documentation that is required in the country.
  • Provides country-level intelligence on site start-up. Ensures that local country regulatory intelligence is maintained on the central repository, e.g. Competent Authority submissions, EC submissions, notifications to data protection authorities, notifications/applications to any other local/federal/national body, and import/ export license applications where these are obtained with RA applications.
  • Provides data protection compliance guidance at a country level on data protection statements that need to be included on those documents which the Sponsor has contracted to the Company start-up group to adapt to local requirements. This will typically include the Principal Investigator/Informed Consent and the CDA/contract template. Provides input in local SOPs and WG.
  • Supports creation of internal training materials for local legislation requirements.
  • Provides input to the team to assist with EC or CA issue resolution at the country level.