Associate Director Country Operations Line Manager

le contenu du travail

• Leadership of dedicated group of Country Operations.
• Ensuring adequate resources for the studies assigned, ensure that workload of direct reports is adequate,
• Development and performance management of direct reports, including implementation of development and training plan and regular coaching of the direct reports. Prepares salary and bonus proposals for direct reports based on their performance in close collaboration with responsible HCO
• Ensuring that study activities at country level comply with local policies and code of ethics and committed activation and recruitment targets
• Contributing to Country feasibility analysis for new potential clinical trials
• Ensuring direct reports deliver allocated trials accordingly with expected timelines, quality and costs
• Contributing to efficient COM organization and its functioning at country level by working closely with responsible HCO. Support HCO and in-Country COM activities as agreed with HCO, such as Site Oversight Visit reports review and onboarding of new in-Country COM functions and team members
• Contributing to the quality improvement of the study processes and other procedures.
• Supporting COM region in initiatives/activities as agreed with HCO.
• Ensuring collaboration with local Medical Affairs team.
  

If COLM takes other role in combination to current responsibilities, please refer to the corresponding Job description.

You will need to have:

• Bachelors degree in related discipline, preferably in life science, or equivalent qualification.
• Experience in the clinical trial process as per GCP and local requirements
• Minimum 8 years of experience in Development Operations (CRA / Sr. CRA / Project management) or other related fields.
• Excellent interpersonal skills, proactivity and assertiveness.
• Manage change with a positive approach for self, team and business. Sees change as an opportunity to improve performance and add value to business.
• Excellent organizational, analytical, influencing and negotiation skills.
• Excellent presentation and communication skills, verbal and written.
• Excellent knowledge of spoken and written English.
• Ability for national and international travel.
• Integrity and high ethical standards.
• The duties of this role are generally conducted in a field environment. As is typical of a field-based role, employees must be able, with or without an accommodation to: travel by public transportation, automobile, train, or plane; work comfortably in a clinical setting; use a computer; engage in communications via phone, video, and electronic messaging; problem solve; engage in complex and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
  

We would prefer for you to have:

• Good knowledge of rare disease clinical development environment
• Line management experience and good resource management skills
• Excellent knowledge of the Monitoring Process.
• Good understanding of the Study Drug Handling Process and the Data Management Process.
• Ability to work in an environment of remote collaborators.
• Excellent decision-making skills.
• Good conflict management skills and ability to handle crisis.
• Excellent team building skills also in cross-functional teams.
• Good intercultural awareness.