Manager of Monitoring, Clinical Research

Nivel cariera

Senior (5-10 ani)

Limbi vorbite

engleză, română

Adresa/ adresele jobului

București


YOUR TASKS AND RESPONSIBILITIES

• Lead a team of 10-12 insourced staff;
• Ensures projects/studies are resourced appropriately by allocating or hiring appropriate staff;
• Accountable for all operational activities related to global & country procedures applicable for Phase I and Phase II-IV clinical trials;
• Manages costs and budget;
• Responsible for Quality Oversight-Oversees Corrective Actions/Preventive (CAPAS) of assigned insourced staff to ensure timely and sufficient resolutions;
• Conducts Monitoring Oversight Visits for each Site Manager;
• Participates in Audit Review Meetings;
• Collaborates effectively with vendors;
• Continuously and proactively identifies and proposes solutions for process improvement opportunities;
• Coordinates responses of audits with Global Quality Management;
• Contributes to development of country clinical investigator network to support the portfolio needs for clinical trials;
• Collaborates with Medical Science Liaison to cultivate and enhance clinical investigator relationships to support business strategy.

WHO YOU ARE

• Bachelor degree with 8 years’ relevant experience in healthcare experience including 4-6 years’ relevant clinical development or clinical operations experience;
• In-depth knowledge of clinical development and drug development process, global clinical development processes, ICH-GCP, applicable legal, compliance and regulatory requirements;
• Leadership, motivational and collaborative skills are critical;
• Ability to lead staff in changing times;
• Strong interpersonal skills;
• Very good administrative, financial and technical skills;
• High degree of flexibility, rapid reaction to changing market needs;
• Ability to work with cross-functional teams;
• Fluent in English and Romanian, both written and spoken;
• Able to work effectively within a multi-cultural, global, matrix organization.

THE OFFER

• Opportunity to work in a research based company with high ethical and work environment standards;
• Dynamic and involving job;
• Opportunities for professional training and development;
• Company car;
• Company benefit package;
• Fixed monthly salary
• Annual performance based bonus.

Application time: until 24 November 2017

Reference Code: Mng Monitoring

Division: Bayer  - Clinical Research

Location: RO-Bucharest

Confidentiality is guaranteed! Only short listed candidates will be contacted!

Deadline for submitting applications: 24 November 2017