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Head of Clinical Operations - India & Asia Pacific
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| #106-MH1319 |
| Health - Pharma |
| Salary negotiable |
| Delhi |
India
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| Permanent |
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| Job Description |
Elite Recruitment Group, are currently looking for a Head of Clinical Operations India & APAC, on behalf of their client, a USA based specialist pharma company.
Reporting to the Vice President and Global Head of Clinical Operations, the Head of Clinical Operations - Asia-Pacific will be responsible for all aspects of Asia-Pacific phase I-IV clinical trials, either contributing as part of a global clinical trial or leading a country(ies)-specific only trial. Key areas include hiring, people management, resourcing, study planning and execution, overall CRO management, identification of project risks and contingency planning, preparation of study related materials, supervision of study related activities and critically building strong and lasting KOL / Company relationships in all APAC countries.
KEY RESPONSIBILITIES
Management of APAC component of global clinical trials and/or leading APAC only trials to ensure that studies are conducted efficiently, on time, and within budget
Management, hiring and development of APAC based clinical operations staff permanent and contract
CRO management directly involved in selection, management and oversight of CROs, including ensuring senior CRO management involvement on key company studies
KOL development ensure that the company develops strong and lasting relationships with country KOLs and site staff
Ensures budget and resource requirements are generated and managed to conduct cost-effective clinical trial programs
Work effectively with the company's USA clinical operations staff to ensure effective running of global trials
Review project status on regular basis and ensures timely execution of project summaries, reports, etc. in accordance with agreed plans, as required.
Ensure the development of approaches to clinical trial designs, collection of trial data, analyses/results, and presentation of results to management and both domestic and global regulatory authorities in multiple or large study management
Help develop, communicate and manage company, policies, and procedures through SOP's and related work processes.
Involvement in development of internal SOPs and clinical operations infrastructure (non-contract)
QUALIFICATIONS
12+ years experience in running clinical trials; including 5+ years line management ideally have experience managing global acute care/hospital based phase III trials
BS and medical background necessary, with advanced degree preferred (MS or PhD)
Excellent people management and leadership skills
Excellent organization and planning skills
Demonstrated ability to work collaboratively with management/peers in a team environment
Strong project management and computer skills (including Microsoft office)
Advanced knowledge of statistics and clinical study design and all aspects of clinical trials
Demonstrated strong leadership and management skills with willingness to be heavily involved in running trials; strong ability to work with very little guidance/supervision with a proactive approach
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