- Manages clinical staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, behavioral and technical coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime. Promotes all aspects of Equal Employment Opportunity policy and Affirmative Action Plan. Assures department adherence to good ethical and regulatory standards.
- Supports study implementation and involved in the planning of study delivery at sites to ensure maximum patient enrolment and delivery.
- Drives medical operational delivery by embedding and creating a culture of
- delivery excellence.
- Actively involved in feasibility, new trends and studies and recommend best
- approach at a country level.
- Involved in the planning of studies to ensure maximum patient enrolment and
- delivery.
- Cascades global strategic business plan and direction to country/territory.
- Leads the medical teams to develop strategies and tactics to support planned growth and to increase efficiency and effectiveness.
- Attends and participates in the weekly delivery calls and give guidance to
- support the achievement of delivery goals.
- Manages and controls costs within agreed budgets where applicable.
- Adheres to applicable regulations and ICH guidelines regarding clinical trials,
- regulatory documents and safety issues. Adheres to COPs/SOPs and study
- specific guidelines.
- Drives compliance with company and sponsor quality objectives ensuring
- effective and efficient best practice processes, procedures and documentation to aid delivery and meet customer requirements.
- Provides or arrange training to all research physicians within the territory (study specific, operational standards, acute performance issues, etc.) specifically including conducting patient appointments in the most efficient and effective manner to maximize results.
- Provides guidance to research physicians regarding the clinical management of patients.
- Monitors all safety variables (AE, Lab abnormalities, changes in medical status, un-blinding request) and discusses all medical concerns with relevant
- stakeholders.
- Provides sound and poised review of the likely risks and benefits of a study to management.
- Provides medical review of adverse events of special interest, serious adverse events and clinical outcomes events reported by study sites.
- Ensures team focuses on the need and urgency to deliver randomizations.
- Develops plans with team to fix leading and lagging metrics.
- Valid medical degree within the country with at least 10 years working as a licensed Physician as well as other medical licences as may be required within country( i.e., dispensing) and at least 8 years experience working in clinical research with PI responsibility
- Valid registration as a medical practitioner, with a medical license in good standing, with unrestricted ability to practice in place of work
- Valid ICH GCP certificate
- At least 5+ years management responsibility, if leading a team
- Strong critical thinking, decision making, analytical and problem solving skills
- Exceptional communication skills and ability to work with a cross-functional team to drive results
- Demonstrated ability to influence and collaborate at all levels throughout the organization
- Excellent written, verbal and presentation skills
- Strong planning, organizational and project management skills
- Ability to manage outside agencies in order to fulfil project objectives
- Self-starter with ability to thrive under pressure in a fast paced environment
- Skilled in Word, Excel, and PowerPoint and proficient with the Internet
- Solid understanding of the clinical regulations as well as practical knowledge of common local, medical practices and treatment habits
- Ability to work with minimal guidance and proactively seek guidance on complex tasks
- Ability to multitask and operate within a deadline driven environment
- Open-minded and dedicated team player who thrives in a dynamic and international environment
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Director Medical Operations - Manchester, United Kingdom - Lifelancer
Description
Key responsibilities are as follows:
Education and Experience:
Knowledge, Skills and Abilities:
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