Clinical Research Manager (Local Project Manager), Ukraine

Get ready to redefine what’s possible and discover your extraordinary potential at Covance. Here, you’ll have the opportunity to personally advance healthcare and make a difference in peoples’ lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you’ll be empowered to own your career journey with mentoring, training and personalized development planning.

Join us as we speed the delivery of groundbreaking therapies and anticipate tomorrow’s drug development challenges, creating new possibilities for our clients—and your career.

We are currently seeking a pro-active Clinical Research Manager to join our expanding FSP team in Ukraine.

Essential Job Duties:

These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties.

• PERFORMANCE: Accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally. 30%
• MANAGEMENT: POC for assigned protocols. Pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments for assigned protocols. Strong collaboration with local CO roles. Forecasts country resource needs. Serves local business needs (signs contracts, manages budgets as delegated). 20%
• QUALITY OVERSIGHT: Responsible for quality and compliance in assigned protocols in country. Oversees CRAs and CTCs on assigned projects. 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. Oversees associate CRMs assigned to the Client and work on training needs in collaboration with functional vendor. 20%
• EXTERNAL CUSTOMER FACING: 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. 20%
• INTERNAL COLLABORATION & STRATEGY: Collaborates internally with local PV, Regulatory, GMA/GHH 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. 10%

Qualifications required:

• University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology
• In lieu of the above requirement, candidates with minimum of four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries or experience in a health care setting will be considered
• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
• Thorough understanding of the drug development process
• Fluent in local office language and in English, both written and verbal

Experience required:

• Good organizational and time management skills
• Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project team and investigative sites preferred.
• Excellent communication skills, oral and written.
• Self-motivation with the ability to work under pressure to meet deadlines
• Works well independently as well as in team environment.
• Detail and process oriented
• Positive attitude and approach
• Interact with internal and external customers with high degree of professionalism and discretion
• Multi-tasking capability.
• Good computer skills with good working knowledge of a range of computer packages
• Ability to lead and develop junior staff
• Flexible and adaptable to a developing work environment
• Minimum of six-eight (6-8) years of clinical research experience