Investigator Initiated Studies Specialist

Recruiter
Smith & Nephew
Location
Leamington Spa
Posted
11 Jan 2018
Closes
17 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
We are actively recruiting two Investigator Initiated Studies (ISS) Specialists to join Smith & Nephew ASAP, one to work within our Sports Med team and one to work in our Wound Management team.

The Wound role can be based in either Hull, Watford or Leamington Spa.

The Sports Med role can be based in either Watford, Hull, Leamington Spa, Memphis (Tennessee) or Andover (Massachusetts)

SUMMARY

The Investigator Initiated Studies (ISS) Specialist will support investigator initiated studies with a specific focus on their division (Sports Med or Wound). This role would need to have a good understanding of the current clinical research within this focus area, to work closely with global clinical strategy and franchise teams. Duties include assessment/development of new IIS proposals, critical appraise the study design and feasibility, reviewing milestones (data and publications) and supporting presentation for Clinical Review Committee. Close collaboration with the business franchise and the division's strategy lead.

Essential Functions

- To manage the divisions Investigator Initiator Studies so that the business has a clear understanding of study objectives and milestone deliverables. To track studies using the tracker systems to monitor study milestone deliverables. Review protocol and budget submission for clinical and scientific merit. Provide support data for scientific and clinical review group meetings

- To work closely with the reference center team and to communicate directly with principle study investigator and study site to better understand study proposal and budgets

- To support the administrative functions associated with the IIS project processing and to help reduce the number of long term/critical actions significantly

- Develop effective working relationship with the internal and external customers on behalf of the CMSA organization

- Provide reports on a weekly and monthly basis

- Provide support, guidance and direction to the SMA team to ensure timely and accurate key product submissions

Experience

- Minimum 3 - 5 years of experience in medical device industry, clinical study center setting or scientific/research field required

- Ability to handle complex and inter disciplinary projects, and demonstrates flexibility in managing changing priorities and strong communication skills

- Advanced negotiation and written and verbal communication skills in English

- Understanding of (GCP) Good Clinical Practice and best practices in clinical study set up.

- Good knowledge of Microsoft Access, Excel, Word, PowerPoint, Outlook, SharePoint, Visio and Project

- Experience in working cross functional

- Coordination and administration skills are required.