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Clinical Trial Associate & Contract/Budget Specialist (Czech/Slovak speaking)

Bespoke Recruitment LTD

Information about the position

  • Place of work: Cork, Ireland
  • Basic wage component (gross) and other rewards: 2 920 - 4 580 EUR/month+ 5% annual bonus, 35,000 euro - 55,000 euro per annum
  • Contract type: full-time

Job description, responsibilities and duties

A multinational pharmaceutical company is looking for various levels or experience within Clinical trial professionals preferably with budget and contract experience to expand their team.
The Trial Capabilities Associate provides clinical trial capabilities in support of clinical development. The associate is accountable to ensure the investigator sites meet requirements to enrol study participants into clinical trials and support ongoing activities during site maintenance and close-out. The associate is responsible for obtaining clinical trial authorizations and ethical approvals, execution of the budget and contract, and activities related to clinical finance, records management and site training. The associate will ensure inspection readiness through a complete, accurate and readily available Trial Master File.

Responsibilities
• Initiate investigator site activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents, serve as the point of contact for a site’s ERB and Competent Authority (CA)(where applicable), communicate and negotiate budgets with site personnel and internal teams, negotiate and obtain fully-executed contract, track and ensure site compliance to required training, and effectively drive timelines aligned with company priorities
• Leverage previous site / review board engagements to efficiently drive new work
• Populate internal systems to ensure accuracy of trial / site performance
• Understand and comply with procurements, legal and financial requirements and procedures
• Populate Trial Master Files and libraries for future reference
• Communicate directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out
• Identify, communicate, and resolve issues
• Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems
• Provide feedback and shared learning for continuous improvement
• Leverage trial prioritization
• Anticipate and monitor dynamically changing priorities

For Clinical Trial Budgets and Contracts Associate:
• The associate plays a critical role in communicating, negotiating and executing budgets and contracts with the appropriate site, team or affiliate personnel
• Communicate directly with sites to enable start-up and maintain an active collaboration with sites and internal team to meet enrolment ready timelines
• Ensure country specific regulatory and data privacy requirements are met
• Populate internal systems to ensure accuracy of trial / site performance
• Understand and comply with procurements, legal and financial requirements and procedures
• Populate Trial Master Files and libraries for future reference


Requirements:
• Bachelor’s degree preferably in a scientific or health related field and clinical research/ Trials experience or relevant experience preferred
• Understanding of the overall clinical development paradigm and the importance of efficient site activation
• Applied knowledge of project management processes and skills
• Ability to learn and comply with financial and legal guidelines and policies (budget and contract)
• Effective communication, negotiation, and problem solving skills
• Self-management and organizational skills
• Fluent Czech/Slovak/Hungarian/Ukrainian/French/Dutch/Flemish or other EU language speaker with fluency in English

Employee perks, benefits

Funded relocation package €2,000 (taxable), plus relocation agency support, plus 2 weeks of accommodation & shopping services for quarantine.
Benefits: Healthcare scheme for you and family, pension scheme, life assurance, Bike to work scheme, good work/life balance, subsidised canteen, educational assistance, electric Sit/Stand Desks, Onsite Gym, Occupational Health Centre, Mothers’ Room and more

Company on whose behalf the position is being filled

Hospitals, medical practice activities, other human health activities

A multinational, research-based pharmaceutical company focused on drug innovation & development to make a positive influence of society's wellbeing around the world.

Requirements for the employee

Candidates with education suit the position

Secondary with school-leaving examination
Follow-up/Higher Professional Education
University student
University education (Bachelor's degree)
University education (Master's degree)
Postgraduate (Doctorate)

Educational Specialization

Clinical Trials

Language skills

Czech - Proficiency (C2) or Slovak - Proficiency (C2) or Ukrainian - Proficiency (C2) or Hungarian - Proficiency (C2) or French - Proficiency (C2) or Dutch - Proficiency (C2)

Advertiser

Brief description of the company

Bespoke Recruitment is a leading provider of Global Language Recruitment solutions to the BPO, Contact Centre, Shared Service Centre, Sales, Gaming, Information Technology and Pharmaceutical sectors. We are both a client and candidate driven company – small enough to care and be good at what we do and large enough to handle tasks with the dedication and professionalism on which our reputation is built.