Clinical Process Analyst, RSU, grade 29/30, office based in Sofia
Perform tasks at country level associated with Regulatory, Start-up (RSU) and Maintenance activities in accordance with
applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and
contractual/budgetary guidelines. May participate in feasibility and/or site identification activities.
- Under general supervision, 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.
- Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions.
- Distribute completed documents to sites and internal project team members.
- 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.
- Review and provide feedback to management on site performance metrics.
- Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
- Inform team members of completion of regulatory and contractual documents for individual sites.
- Review, track and follow up the progress, the approval and execution of documents, including contracts, regulatory, ethics, ICF and IP Release documents, in line with project timelines.
- Provide local expertise to RSU leads and Project team during initial and on-going project timelines planning.
- Perform quality control of documents provided by sites.
- May have direct contact with sponsors on specific initiatives.
- May perform Site Selection Visits if a trained monitor.
- May participate in feasibility and/or site identification activities.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- In-depth knowledge of clinical systems, procedures, and corporate standards.
- Fluent in English, additional language is an asset
- Effective communication, organizational, planning and interpersonal skills.
- Ability to work independently and to effectively prioritize tasks.
- Ability to work on multiple projects.
- 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.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor’s Degree in life sciences or a related field and 1 year’s clinical research or other relevant experience; or equivalent combination of education, training and experience.
- Extensive use of keyboard requiring repetitive motion of fingers.
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
- Regular sitting for extended periods of time.
- May require occasional travel.
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