SSU & Regulatory Specialist II
Syneos Health
Buenos Aires, Argentina
hace 2 días

JOB SUMMARY

Performsassigned activities within the country that lead to start-up of investigativesites in all phases of clinical trials.

Responsiblefor delivery, with moderate oversight from the SSU Country Manager andspecialist knowledge in one or more of the following functional areas : investigator site contracts, ethics and regulatory submissions, and reviews ofessential documents required for site initiation.

Ensures local activities are undertaken in accordancewith agreed timelines, allocated budgets, and required quality standards.

Ensures an efficient start-up process onassigned studies.May act as maincontact with Regulatory Authorities (RA) and Central / Regional Ethics Committees(ECs).

Under the direction and somelevel of supervision of the Project Lead (PL) or SSUL as appropriate, maydirectly interact with Customers when receive requirements from RA or otherlocal regulatory party.

Accountable tothe PL / SSUL at the project level and line manager for deliverables. At aproject level, may act as SSUL for local studies.

May provide support as the Country Start-UpAdvisor (CSA).

JOB RESPONSIBILITIES

  • Responsiblefor the quality deliverables at the country level; follows project requirementsand applicable country rules, with moderate oversight from the SSU CountryManager.
  • Workswithin the forecasted submission / approval timelines and ensures they are compliedwith and tracks milestone progress in agreed upon SSU tracking system in realtime;
  • if forecasted timelines are not reached : investigates and provides clear rationale for delays, provides supporton contingency plan to mitigate impact, and escalates the issue as soon asidentified.

  • Monitorsbasic financial aspects of the project and the number of hours / tasks availableper contract; escalates discrepancies in a timely fashion.
  • Reviewsand complies with Standard Operating Procedures (SOPs) and Work Instructions(WI) in a timely manner, keeps training records updated accordingly and ensurestimesheet compliance.
  • Supportscontinuous improvement of quality in all Site Start-Up (SSU) components at thecountry level where assigned (submissions, essential document collection,communication to Competent Authorities and ECs, etc.).
  • Ensureall relevant documents are submitted to the Trial Master File (TMF) as per CompanySOP / Sponsor requirements.
  • Responsiblefor one or more of the following functions at the country level :

  • Local Submissions Specialist - Follows the project directionprovided by the designated country start-up advisor (CSA) and SSUL.
  • May serve as a point of contact for thePM / SSUL (or designee) during start-up on allocated projects.Complies and / or reviews essential documentpackages for site activation and may also be involved in essential documentcollection from site.

    Prepares andsubmits Central EC Applications, Local EC Applications, RA Applications, andother local regulatory authorities or hospital approval submissions asrequired.

  • Preparesongoing submissions, amendments, and periodic notifications required by centraland local EC and RA and other local regulatory authorities as needed within thecountry;
  • includes safety notifications as required by local rules, withmoderate oversight from the SSU Country Manager.

  • CountryStart-Up Advisor - Acts as Subject Matter Advisor for in-country performancewithin the Site Start-Up.Supports country-levelintelligence on start-up (SU) and clinical trial regulatory (CTR).
  • Ensures that local country regulatoryintelligence, as it pertains to the activities of the local SU and CTR team, ismaintained on the central repository, e.

    g., Competent Authority submissions, ECsubmissions, notifications to data protection authorities,notifications / applications to any other local / federal / national body, andimport / export license applications where these are obtained with RAapplications.

    In absence of legaladvisor or dedicated subject matter may provide support for data protection atthe country and provide guidance at a country level on data protectionstatements that need to be included on those documents which the Sponsor hascontracted to the Company start-up group to adapt to local requirements.

    This may include the PrincipalInvestigator / Informed Consent and the Confidential DisclosureAgreement / contract template.

    Providesinput in local SOPs and WI.Supportsthe creation of internal training materials on local legislationrequirements.Provides input to the teamto assist with EC or CA issue resolution at the country level.

  • LocalSite ID and Feasibility Support Provides support with site selection lead andPM / SSUL to ensure that the appropriate sites are selected for individualstudies based on the requirements of the clinical trial.
  • LocalInvestigator Contract and Budget Negotiator Provides support to SSUL to agreeon country template contract and budget.
  • Produces site-specific contracts from country template.Provide support in submissions for proposedcontract and budget for site.

    Provides support in negotiating budget andcontract with site via Site Contracts Service Centre and SSUL with Sponsoruntil resolution of issues and contract execution.

    Performs quality control andarranges execution of CTAs as well as archival of documents into repositoriesand capture of metadata.

    Qualifications

    QUALIFICATION & REQUIREMENTS(please indicate if preferred’)

  • Bachelor’s Degree,
  • Detailed understanding of clinical trial process across PhasesII-IV and ICH GCP.
  • Ability to understand clinical protocols and associated studyspecifications.
  • Detailed understanding of clinical trial start-up processes.
  • Ability to manage external vendors to contract effectively.
  • Strong organizational skills with ability to handle multiple taskseffectively.
  • Strong written and verbal communication and interpersonal skills.
  • Ability to manage multiple project budgets with increasedcomplexity and value.
  • Quality-driven in all managed activities.
  • Good negotiating skills.
  • Good problem-solving skills.
  • Demonstrated ability to work independently as well as part of ateam.
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