Job Overview :
Discover new opportunities to grow your career as a Covance FSP Start-Up Associate Project Manager.
Are you someone with previous regulatory submissions experience looking for developing your career within this area?
At Covance we are recruiting for a Start-Up Associate Project Manager to work sponsor dedicated into a top 5 pharmaceutical company to be based in Turkey.
At Covance, you can redefine what is possible and discover your extraordinary potential within our Functional Service Provider team (FSP).
As a Covance employee dedicated to an FSP project you will bring your specialized discipline to a core team working directly with one sponsor.
Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance Covance has an FSP opportunity to match your area of expertise.
Each FSP offers a unique opportunity to be a part of the drug development cycle and see a product through to launch. We have multiple partnerships giving you the variety and the flexibility to stay with sponsors, try a new external secondment or work in house on Covance studies.
With the support of exceptional people and an energized purpose, you’ll be empowered to own your career journey with dedicated mentoring, training and personalized development planning.
Assignment of site numbers
Identification of patients documents required for translation
Assessment of local sourcing availability of drug
Start-up timelines estimation
Oversight and coordination of CTC tasks during validation (support)
Coordination of collection of site documents required for EC / HA submission
Local ICF adaptation
Review and adaptation of patient recruitment and retention materials
Cooperation and support of contract / financial team during contracting process
Providing update to study team members, i.e. CRM, CRAs, RCPM, CTC regarding current start-up status
Local IMP, drug and non-clinical supplies management
Education / Qualifications :
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
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
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