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Job Description
The person contributes to CTC capacity/resource planning activities to ensure efficient allocation of resources and work. Responsibilities include, but are not limited to:
• Has significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up
• Ensure and oversee proper on‐boarding and off‐boarding of employees, compliance to initial and ongoing trainings.
• Train and oversee the CORE competencies, ICH‐GCP knowledge, Clinical Research environment etc.
• Assure adherence to GCP guidelines, processes and procedures related to direct reports’ activities and performance.
• Ensure direct reports are compliant to the timelines and key business metrics. • Review and approve timesheets, GTT compliance, expense reports, time‐off requests and provide proper oversight of CTC's productivity/utilization.
• Provide input for capacity planning, including reporting of current manpower and forecasting of CTC capacity and needs, to provide efficient use of resources.
• Work with CRDs, TA-Heads, CRMs, CRA-Manager, Sr. COM, CRAs, Partners and other functions to ensure consistency of processes and protocol implementation across the country, to reduce variability and provide predictability.
• Interacts with CRMs and sites as needed to resolve operational issues, to meet commitments in a timely manner and in coordination with the study CRM and CRA.
• Interface with GCTO partners on clinical trial execution as assigned; including acts as lead liaison with CTC FSP partners in facilitating coordinated process and country delivery.
• Escalates site performance issues to CRM and CRD/TA-Head.
• People and Resource Management: o Manages CTC – career development, performance reviews, etc., including addressing low performance situations, and taking appropriate actions. o Supports and resolves escalation of issues from CTCs. o Manages capacity/resource planning activities to ensure efficient allocation of resources and work.
Manage local conflicts between resource and work. Ensures CTC compliance to corporate policies, procedures and quality standards
Current Contingent Workers apply
Language(s) Job Description:
• Demonstrates proactive leadership and must be able to in/directly influence vendors, external partners and country managers to deliver these commitments within specified timelines with minimal oversight from the line manager.
• Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally. He/she is an independent decision maker with a clear understanding of the pros and cons of each decision and takes ownership of decisions
• Ability to work independently and in a team environment
• Excellent people management, time management, project management and organizational skills
• History of strong performance and leadership
• Skills and judgment required to be a good steward/decision maker for the company
• Fluent in Local Language and business proficient in English (verbal and written)
• Excellent working knowledge of all applicable ICH/GCP regulations and Good Documentation Practices and ability to work within these guidelines
• Expertise in and excellent working knowledge of core trial management systems and tools
• Strong coordination and organizational skills.
• High emotional intelligence
• Strong leadership skills with proven success in people management
• Excellent interpersonal and communication skills, conflict management
• Demonstrated ability to build relationships and to communicate effectively with internal stakeholders and external partners
• Fluency in both English and local language Qualification & Experience:
• Minimum of 5 years experience within Clinical Research, preferred experience in the role of CTC, CRA or similar role
• Line management experience preferred or at the minimum team leader experience Educational Requirements: Required:
• Bachelor's Degree (or comparable) in Business Administration/ Life Science Preferred:
• Advanced degree, (e.g. BA/BS or higher) with a strong emphasis in science and/or Clinical Research Management/Administration.
*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
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