We are on the lookout for a driven individual with a passion for the medical device industry. One of our clients is looking to add a strong Clinical Affairs Manager to their team:
1) Provide strategic insight to the project team regarding product development plans
2) Manage interactions with FDA or other regulatory authorities
3) Support planning, preparation and submission of INDs and BLAs and NDAs
4) Ensure study sites develop study protocols and systems and execute on commitments that further critical care interests, especially for investigator initiated studies
5) Support developing clinical processes and procedures that help maintain appropriate clinical compliance at sites and internally
6) Manage and collaborate with clinical affairs personnel to meet business and clinical trial objectives
7) Be responsible for management of clinical trial budget
8) Fully accountable for the results and achievements of the area
9) Implement global study support strategies and initiatives
10) Act as clinical expert to core team(s) for proper clinical trial design, planning and execution
More questions? Want to know the Salary range? Keep reading.
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1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the medical device industry is strongly preferred
4) Preference will be given to people have recent experience in clinical management
This position is critical to the team and requires a qualified individual to fill the role... someone with a real go-getter attitude!
Sterling-Hoffman Life Sciences is the premier recruitment firm in North America for companies involved in the research, clinical development, manufacturing and distribution of drugs and devices that allow patients to live healthier and more fulfilling lives. Leveraging a network of relationships in every major city – including New York, San Francisco, Raleigh-Durham, Chicago, Dallas, Denver and Los Angeles – Sterling-Hoffman Life Sciences is ideally positioned to assist fast growing CROs, pharmaceutical companies, biotech firms and medical device players in their quest to recruit the best people.