Associate Director, Clinical Operations

Associate Director, Clinical Operations

Incyte

Martinsried, Germany

Summary

The country Associate Director Clinical Operations responsibilities include leadership and local strategic planning and operational delivery of assigned clinical trials to support Incyte’s pipeline, in accordance with the appropriate quality standards, including ICH/GCP/GPP standards, Incyte SOPs, local operating guidelines and local requirements, as applicable. The Country Clinical Operations Manager works locally toward Global Development Operational targets for recruitment and completion of R&D sponsor trials within timelines and budget. In addition, the position requires management of local CRAs and local oversight of vendors.

Responsibilities

  • Has accountability and oversight for all assigned studies at country level in accordance with the overall plan and under the direction of the global team (Global Clinical Trial Manager) including adherence to quality, timelines and budgets;
  • Plans and executes country study goals and commitment, and ensures compliance to relevant processes;
  • Collaborate cross functionally with Incyte country staff to build strong interaction at local level (e.g. Medical Affairs, Medical Science Liaisons, medical team, etc…);
  • Attend Global study teams meetings, representing the country and Clinical Research Associates (CRA) and provides Global study team with feedback from a country perspective;
  • For in-house studies, works with the Study Start-up team, ensures timely submission of all ethical and administrative submissions and helps to ensure their appropriate approval;
  • Oversees study feasibility, site monitoring performance and all relevant activities for assigned studies;
  • Collaborates with the Global Study Team, to develop and execute, when necessary, local contingency plans and risk management plans, identifying critical issues for the country;
  • Collaborates in local quality/compliance reviews, internal audits, and regulatory inspections, ensuring inspection readiness at all times and oversee implementation of Corrective Action Plan for assigned studies;
  • Provides direct line management to CRAs by setting clear goals and expectations, monitoring performance, providing overall motivation, support, feedback and follow-up to ensure team performance is fully optimized;
  • Develops, builds and maintains optimal relationships with key institutions within the country, working closely with Medical Affairs/other local departments regarding site engagement strategy;
  • Ensures that clinical data from sites are delivered in accordance with established dataflow, timelines and quality;
  • Ensures that Incyte Clinical Trial Management System tracking tools and other systems are populated and maintained up-to-date for the country for assigned studies;
  • Leads and/or organizes and/or participates in local or regional meeting and training sessions to implement country level recruitment plans;
  • Communicates regularly on country study(ies) status and escalates unresolved issues appropriately to the country Medical Director and/or ED, Clinical Operations and/or Global Study Team;
  • Proactively incorporates learning and recommendation from study debriefs and best practices;
  • Maintains oversight and ensures consistency across studies in the country;
  • Contributes to improve global and local processes;
  • If appropriate, review CRO monitoring plans and training plans for studies conducted in the country;
  • Work closely and in collaboration with Development Operations and the ED, Clinical Operations;
  • Perform other duties as assigned by management;
  • Participate in global and local initiatives as required.

Requirements

  • Minimum Bachelor’s degree with at least 5-7 years of experience in Clinical Trial operations in pharmaceutical/biotechnology industry or Clinical Research Organization, or equivalent, including at least 3 years in a role of primary responsibility for clinical trial execution and management. Local experience is a plus;
  • Thorough understanding and experience in global clinical trials in a diverse range of patient populations with preferred oncology experience;
  • Good knowledge and experience of working with external specialist vendors;
  • Direct management experience and supervisory responsibility. Demonstrated leadership and management skills;
  • Excellent written/verbal communication skills;
  • Excellent interpersonal, organizational, and problem-solving skills, confidence, and ability to work effectively with a wide variety of medical, research and administrative personnel;
  • Proficient in Outlook/Word/Excel/PowerPoint;
  • Must be able to travel (domestic and international) up to 25%;
  • Goal oriented, self-starter with proven ability to work independently;
  • Able to proactively identify issues and provide solutions for resolution;
  • Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines and quality.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job

More Job Searches

Incyte     Germany     Clinical Research     Manager and Executive     5 Years+ Experience    

© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

Newsletter | Recruit | Advertise | Privacy | Contact Us

© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

This website uses cookies to make your experience better. Continued use of this website means you accept our cookie policy.  Accept Cookies