Regulatory Affairs and Start Up Specialist

IQVIA RDS Slovakia, s. r. o.

Place of work
Vajnorská 100, Bratislava
Contract type
full-time

Information about the position

Job description, responsibilities and duties

PURPOSE
Manage and 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 pre-award activities, proposals and oversights of the scope of work at country level.

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.

Basic wage component (gross) and other rewards

min. wage 2200 EUR gross/month BASED ON EXPERIENCE

Requirements for the employee

Candidates with education suit the position

University education (Bachelor's degree)
University education (Master's degree)
Postgraduate (Doctorate)

Language skills

English - Advanced (C1)

Personality requirements and skills

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• English on business level, certification in English is welcome
• Working with databases , computer literacy
• 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.
• Ability to manage 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 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience.

Advertiser

Brief description of the company

IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.

Whatever your career goals, we are here to ensure you get there!

We invite you to join IQVIA™.

Number of employees

1000 an more employees

Company address

IQVIA RDS Slovakia, s. r. o.
Vajnorská 100/B
831 04 Bratislava - mestská časť Nové Mesto
https://www.iqvia.com/

Contact

Contact person: Erika Kostkova
E-mail: send CV
ID: 3661751   Dátum zverejnenia: 8.8.2019   Základná zložka mzdy (brutto) a ďalšie odmeny:   min. wage 2200 EUR gross/month BASED ON EXPERIENCE