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Clinical Trial Manager

Date: Dec 9, 2021

Location: Dunfermline, GB, KY11 8GR

Company: Optos

Clinical Trial Manager

Permanent

 

ROLE SUMMARY

We are currently looking for a Clinical Trial Manager to join our Clinical Department based in Dunfermline. You will be responsible for providing management in the initiation, design, conduct and reporting of strategic ultra-widefield clinical trials. You will also be responsible for providing ownership and leadership of company sponsored clinical studies to ensure high quality delivery on time to budget. 

 

The Clinical Trial Manager’s main purpose will be to manage ultra-widefield Multicentre Collaborative Group clinical trials and support Investigator-led research. You will be a Clinical Trials Leader within the organisation with a key role in strengthening clinical development deliverables, scientific evidence, and post-market clinical trials

 

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Responsible for the management and delivery of in-house and external medical device studies.
  • Providing input into; protocol writing, CRF design, Study initiation, conduct, monitoring, data collection and clinical study report writing. 
  • Deliver to clinical project milestone: Planning and tracking to ensure all clinical studies are progressing according to project plan, protocol quality standards, timeliness, and budget.
  • Support management to establish, organise, support and direct clinical trials in accordance with ICH GCP, applicable country regulations, and corporate SOPs.
  • Experience in developing contractual agreements within a range of partnerships and services/regulatory guidelines and provide clinical trial expertise. 

 

 

MINIMUM QUALIFICATIONS

  • BA/BSc in related field required or equivalent education gained through allied work experiences.
  • 5 years clinical trials, medical device and/or ophthalmology experience.
  • Familiarity with the medical devices sector and have experience of managing Pre- and Post-marketing clinical trials would be an advantage.
  • Trained in ICH/GCP and (inter-) national guidelines and requirements.
  • Must have a high sense of urgency and decisiveness; results, action, and detail-oriented approach with a “can do attitude”.
  • Convey high ethical and performance standards.
  • Demonstrated ability to lead complex clinical projects and get “buy in” from key players at study sites.
  • An ability to remain focused within tight deadlines and manage time effectively.
  • Strong team player with flexible attitude to work priorities.
  • Good computer skills (MS Office applications).

 

 

BENEFITS

At Optos, we offer a highly competitive compensation and benefits package.

 

EQUAL OPPORTUNITIES EMPLOYER

We are an equal opportunities employer and welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation, age or protected veteran status.

 

If you feel you have the necessary skills and experience and want to join a great team, please click on the Apply button!