Ref #: 25639

Employment type: Permanent - Full-Time

Location: Poland

Description

Responsibilities
• Responsible for the conduct of some study activities in accordance with FDA regulations, ICH GCP guidelines and
SOPs/ QDs
• Manage some components of clinical trials from study outline / protocol through CSR completion. Includes
reviewing and implementing protocols, site selection, designing CRF, review of data management plans, developing monitoring plans and training site staff, internal staff and monitors on protocol specific procedures
• Maintain study timelines during the planning, initiation, ongoing/active and study completion stages of clinical trials
• Experience or awareness in site selection (qualifications), SIVs, Monitoring Visits and Close Out Procedures.
• Manage preparation and overseeing budgets successfully
•Lead review of supplier SOWs and accuracy of clinical outsourcing vendor agreements including CRO, IRT, Central lab, eCOA, ECG and electronic data capture as well as manage vendors with respect to contracted scope of work and budget
•Demonstrate a commitment to cultivate innovation, drive operational excellence with activities on time, highest quality and within budget.

Leadership
• Demonstrated ability to efficiently work with other GSMs in the same study
•Ability to collaborate effectively with cross-functional team members and external partners using collaborative negotiation skills
•Experience in managing and leading international meetings (e.g. meetings with vendors)
•Ability to anticipate potential issues, proactively identify ways to resolve/ mitigate, timely escalate issues with appropriate action plans
•Capability to challenge decisions/status-quo/requests using risk management approach (e.g. unrealistic timelines, unplanned database snapshot.)
• Display stakeholder management skills (e.g. ability to manage expectations).

Oversight & Coordination
•Project Management background
•Good organizational skills: results and quality oriented with the ability to multi-task, skill in establishing priorities and meeting deadlines.
•Ability to develop and maintain an optimized planning related to his/her scope of activities, in relation with other
functions (including identification of critical path)
•Ability to work autonomously, to efficiently and effectively provide status reports
• Ability to identify and implement synergies
• Ability to appropriately delegate responsibilities in case of outsourced activities.

Communication
• Good written and verbal communication skills
• Good negotiation skills
•Strong English skills (verbal and written if English is the second language) i.e., ability to exchange fluently (incl. negotiation), lead international meetings, write meeting minutes/ emails/ study documents / internal & external communication
•Alert on purpose, communicate on issues with proposed action plans.
•Contribute to building a positive team spirit

Required
•Degree in scientific discipline preferred, equivalent RN preferred
•Experience of working internationally
•Experience in coordinating vendors

What is offered
•Competitive Salary + career Progression
•Home based
•Perm position
•Must be Eligible to work in the EU


If you are seeking an international company who is committed to development and training and the opportunity for career progression, please get in contact.