Covance, a $15 billion Fortune 500 company, with operations in over 97 countries, has led the way in improving patient outcomes through visionary data sciences over the last five decades. We have supported 100% of the top 50 drugs in the market and all the oncology medicines approved in 2016. Our team of over 57,000 across the globe is committed to advancing healthcare and bringing new medicines to market sooner. Our unique perspectives, built from decades of scientific expertise and precision delivery, help our clients identify new approaches and anticipate tomorrow’s challenges as they evolve. Driven by a passion for excellence and a relentless commitment to quality, we unlock opportunities that advance innovation and deliver the promise of a healthier world. Together, with our large pharmaceutical and emerging biotech clients, Covance transforms today's health care challenges into tomorrow's solutions.
Post : Clinical Team Lead
Education/Qualifications
• University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution;
• In lieu of the above requirement, candidates with six (6) or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered;
• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries;
• Thorough understanding of the drug development process.
Preferred
• Experience as a Senior Clinical Research Associate;
• PMP Qulaification.
Experience
• Regional Project Manager experience in a Clinical Research Setting.
• An ability to demonstrate comprehensive understanding of:
- ICH/GCP guidelines;
- Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs;
- Site monitoring and study site management requirements;
- Applicable regional regulatory requirements;
- Trip report review, risk planning, study plan development, resource planning and data management oversight;
- In lieu of the above requirements, candidates with 2 years supervisory experience in a health care setting and four 4 years clinical research experience (including monitoring) in the pharmaceutical or CRO industries will be considered.
Additional requirements
• Demonstrated ability to work with minimal supervision;
• Demonstrated good planning and organization skills;
• Good computer skills with good working knowledge of a range of computer packages;
• Demonstrated effective and professional verbal and written communication skills;
• Ability to train, lead and develop junior staff;
• Ability to understand and work with financial information;
• Ability to resolve project-related problems and prioritizes workload for self and team;
• Ability to work collaboratively within a project team;
• Ability to work efficiently and effectively in a matrix environment.
Additional Information:
Experience : 6+ years
Qualification : University/college degree
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: Clinical Operations
Job Number : 2018-18462
End Date : 25th April, 2018
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