Clinical Research Manager – Poland (Office Based in Warsaw)
Clintec are recruiting two Clinical Research Manager's to join our growing CRO in Poland. These are full-time and permanent contracts working office-based in Warsaw.
The Clinical Research Manager will be primarily accountable for the end to end performance for assigned protocols in Poland in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
- Main Point of Contact (POC) for assigned protocols and link between Country Operations (CO) and clinical trial team (CTT).
- Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
- Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
- Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
- Performs Quality control visits as required
- Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration
- Responsible for creating and executing a local risk management plan for assigned studies
- Ensures compliance with CTMS, eTMF and other key systems in assigned studies
- Escalates as needed different challenges and issues
- Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies
- Country POC for programmatically outsourced trials for assigned protocols.
- Serves local business needs as applicable in his/her country (If delegated can sign contracts and manage budgets)
- Collaborates internally with HQ functions and locally with internal stakeholders to align on key decisions in his/her studies.
- As a customer-facing role, this position will build business relationships and represent company with investigators
- Shares protocol-specific information and best practices across countries\clusters
Bachelor’s degree in science (or comparable)
Advanced degree, (e.g., Master degree, MD, PhD)
- Strong Clinical Research Experience including previous CRA experience
- Knowledge in Project/Site Management.
- Strong organisational skills with demonstrated success required.
- Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments
- Requires strong understanding of local regulatory environment
- Strong scientific and clinical research knowledge is required
- Oncology experience is preferred
- Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
- Strong leadership skills
- Ability to identify problems, conflicts and opportunities early and lead, analyse and prepare mitigation plans and drive conflict resolution is critical.
- Required to negotiate skilfully in tough situations with both internal and external groups; settle differences with minimum noise
- Educational/pedagogic, diplomatic and empathic skills to effectively build and maintain professional relationships with investigators and other external stakeholders
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.