Clinical Research Manager – Hungary - Home or Officer Based
Clintec is actively recruiting for a Clinical Research Manager (CRM) to join our expanding global CRO. The CRM will be accountable for performance and compliance for assigned protocols in Hungary, in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. This is a permanent opportunity working either home or office based.
- Pro‐actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments for assigned protocols.
- Forecasts country resource needs.
- Serves local business needs (signs contracts, manages budgets as delegated).
- Responsible for quality and compliance in assigned protocols in country.
- Oversees CRAs and CTCs. Oversees training compliance.
- Performs quality control visits.
- Reviews Monitoring Visits Reports and escalates performance issues and training needs to functional vendor and internal management as needed.
- Responsible for collaboration with functional outsourcing vendors, investigators, other external partners.
- Oversees country and site validations, site selection and recruitment in assigned protocols.
- Responsible for clinical trial education to sites. Country POC for programmatically outsourced trials for assigned protocols.
- Collaborates internally with cross-functional teams to align on key decisions in countries. Supports local and regional strategy development consistent with long‐term corporate needs in conjunction with CRD and Regional Operations.
- Significant impact on the ability to effectively conduct clinical studies and develop the pipeline, while maintaining local regulatory and compliance requirements in countries. The position has a significant impact on how a country can deliver country‐specific trial commitments and objectives.
- As a customer facing role, this position will build business relationships and represent the company with investigators, functional outsourcing partners and other external partners and therefore have a significant impact on country‐level customer relationships.
- Oversee country commitments, compliance and training needs.
- Works collaboratively with Country and Regional Operations; Pharmacovigilance, Regulatory, Global Medical Affairs and Global Human Health internally; and with external functional outsourcing vendors.
- Requires coordination and alignment with the regional and broader organization. Additionally, will work to build and maintain relationships with investigators and other external partners
- Provides oversight of contract workers (CRAs, CTC) and works closely with external vendors, site investigators.
Required Qualifications, Skills & Experience
- Master in Science (or comparable), Advanced degree (MD, PhD) desirable but not essential
- Strong clinical trial management experience
- Strong leadership skills
- Knowledge in Site Management.
- Excellent oral and written English and Hungarian
- Ability to make decisions independently and oversee important activities relevant to clinical research activities in the country
- Understanding of local regulatory environment
- Ability to identify problems, conflicts and opportunities early and lead, analyze and prepare mitigation plans and drive conflict resolution
- Ability to negotiate in tough situations with both internal and external groups
- Strong scientific and clinical research knowledge
- Good understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously
- Ability to build and maintain professional relationships with investigators and other external stakeholders, requiring strong communication, educational/pedagogic, diplomatic and empathic skills
- Proven ability to collaborate and lead high performing cross‐functional teams also in a virtual environment.
- Strong leadership skills (scientific and business) and ability to coordinate and lead local teams to high performance.
Clintec International is a UK-based, dynamic privately owned full service Contract Research Organization with a presence in over 50 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries for over a decade and assist in their key product development efforts. At Clintec International, we pride ourselves on delivering high quality, flexible and professional services/solutions for our clients. Clintec International has a wealth of experience in managing clinical trials in all major therapeutic areas including oncology, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.
Clintec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process. We have strong partnerships with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects - with the opportunity to develop, progress and travel globally. ClinTec International offers a competitive salary and rewards package.