Regulatory & Start Up Specialist
IQVIA
Karachi, Pakistan
2d ago

Job Responsibilities :

  • Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Leadership and GICS.
  • Ensure adherence to standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables and to project timelines.

    Where applicable, act as a Country Lead for projects with no regional Lead assigned.

  • Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions.
  • Prepare site regulatory documents, reviewing for completeness and accuracy.
  • Review, prepare and negotiate site contracts and budgets with sites, if applicable.
  • Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
  • Ensure contracts are fully executed, regulatory documents and approvals are granted, IP Release authorized and specific project deliverables are completed.
  • Review and provide feedback to management on site performance metrics.
  • Review, establish and agree on project planning and project timelines. Ensure overall project efficiency and adherence to project timelines.
  • Ensure monitoring measures are in place and implement contingency plan as needed.

  • May contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
  • May assist in pre-award activities including bid defenses, proposals and oversights of the scope of work at country level.
  • May provide input into contract and budget template development.
  • May support importation activities.
  • May have direct contact with sponsors on specific initiatives.
  • May act as Local Regulatory, Ethics and Contract Expert and reviewer of ICF.
  • May act as mentor, and prepare and deliver country-specific training, for less experienced staff.
  • May participate in feasibility and / or site identification activities.
  • May perform Site Selection Visits if a trained monitor.
  • Job Requirements :

  • Min. 1 year of relevant experience
  • Bachelor’s Degree in life sciences or a related field and 1- 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience.
  • In-depth knowledge of clinical systems, procedures, and corporate standards.
  • Good negotiating and communication skills with ability to challenge, if applicable.
  • Effective communication, organizational, and interpersonal skills.
  • Ability to work independently and to effectively prioritize tasks.
  • Knowledge and ability to apply GCP / ICH and applicable regulatory guidelines.
  • Knowledge of applicable regulatory requirements, including local regulations, , SOPs and company’s Corporate Standards.
  • Understanding of regulated clinical trial environment and knowledge of drug development process.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients
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