Clinical Research Manager- Sofia
Deadline: 21st July 2017
Novo Nordisk is a focused healthcare company and the world leader in diabetes care.
We are actively working to change the course of the diabetes pandemic, improve the daily lives of people with diabetes, and to expand the possibilities for people with haemophilia.
Novo Nordisk Pharma EAD is the leading diabetes care company in Bulgaria. It has a developed and highly effective Clinical, Medical & Regulatory department. CMR department provides high quality local execution of clinical trials, state-of-art local scientific events and medical education, as well as excellent regulatory performance.
We seek to hire a Clinical Research Manager
The Job and key accountabilities
• Creates affiliate clinical long-term plan in cooperation with CMR Head & BA Europe East CMR function.
• Ensures conducting clinical trials with high quality in accordance with protocols, SOPs, local regulations and ICH-GCP guidelines, including: site feasibility, sites selections and supervises clinical operational staff activities.
• Secures all agreed milestones in the trials are kept.
• Ensures agreed numbers of patients are recruited within defined timeframe.
• Ensures clinical quality management system deliverables are met as requested.
• Identifies possible challenges for the study progress during the planning and execution phases and proposes solutions to overcome them.
• Responsible for compliance to requirements within clinical area and own area of responsibilities.
• Maintains current knowledge of therapeutic areas, SOP’s, local regulations and ICH GCP guidelines.
• Plans, executes and supervises clinical budget and resources.
People Management & Leadership:
• Provides leadership to NN Bulgaria clinical staff, recruits, motivates, coaches and develops employees reporting to him/her.
• Sets the goals and responsibilities for clinical operational staff and follows-up on realization.
Relations with internal/external stakeholders:
• Builds strong relationships with investigators to support clinical trials.
• Closely cooperates with internal stakeholders within local affiliate, BA Europe East and HQ as needed.
• Cooperates with all other relevant health authorities and structures responsible for conducting clinical trials in Bulgaria.
• Meets all local and company requirements with respect to safety reporting, quality & legal aspects of trials.
Clinical Research Manager reports to affiliate Clinical, Medical & Regulatory Head and collaborates with Business Area Europe East CMR function, as well as with all relevant corporate functions. The position is permanent and is based in Sofia, Bulgaria.
• University degree related to life science.
• Significant experience within clinical trial operations area (previous experience as Clinical Research Manager/Clinical Team Lead, Local Trial Manager).
• Values and behavior aligned with the Novo Nordisk Way.
• Understanding of pharmaceutical market.
• Ability to think strategically and take a long-term perspective.
• Self-aware, mature, flexible, ready to work independently (self-driven) and via others.
• Stakeholder management skills and ability to create long-term value-adding collaboration with external & internal stakeholders.
• Good process mapping and simplification skills.
• People management skills (ability to build trust, lead, coach, motivate and develop employees in clinical department).
• Fluent in English – written and spoken
• Driving license.
If you think you have what it takes to join our Team in Bulgaria, please send your CV no later than 21st July 2017.
For more info - click here!