Clinical Operations Manager
Would you like to be part of an organisation which is committed to improving patient lives worldwide through education, collaboration and innovation?
Do you want to make a difference?
If the answer is ‘yes’ then you’re just the kind of person we’re looking for!
We are looking for an experienced Clinical Operations Manager who is an organised and passionate individual. This role is newly created and reports directly into our Global VP of Medical and Scientific Affairs. This role will drive the execution of key clinical studies and manage a team of Clinical Affairs Managers and Clinical Research Associates.
This role requires occasional international travel.
The Role
- Design and coordinate external and internal in vitro diagnostic studies for the support of regulatory submissions and future product development.
- Drive the execution of clinical studies while managing timelines, budget, risk, resources and quality standards.
- Oversee the development of clinical study protocols, informed consent forms, case report forms, clinical study reports and other relevant study documents.
- Develop, negotiate and manage study budget and study agreement for external clinical studies.
- Responsible for study documentation management in full compliance with GCP and internal SOPs.
- Communicate effectively with key stakeholders and keep them up to date on all clinical study information, including strategies, risks and progress.
- Coach, develop and mentor colleagues within team
The Ideal Candidate
- Is a BSc in Biochemistry, Immunology, Regulatory Affairs or similar.
- Has a minimum 5 years' relevant professional experience in the medical device industry, ideally in the in vitro diagnostics field.
- Advanced degree in the relevant field or Certified Clinical Research Associate certification is
- Possess thorough understanding of GCP, ICH guidelines, ISO Standards, FDA/EU regulations.
- Has strong knowledge of all phases of product development, including development, analytical and clinical performance evaluation, post market studies, regulatory and manufacturing compliance.
- Demonstrate strong organizational and project management skills, including excellent record-keeping skills and good documentation practice.
- Has advanced written and oral communication skills.
- Familiarity with the technology of immunoassay analysers and knowledge of the diagnostic immunology and hematology fields are a plus.
Working for us:
Founded in 1986 by a group of former researchers based at the University of Birmingham, Binding Site is today recognised as a market leader in the development of products for the investigation of a range of disorders involving immunodeficiency.
The Company is built on the success of its people and values them as its key asset. Integral to Binding Site is creating a diverse and inclusive culture which welcomes and creates diversity of thought, action, and innovation where all 1,200 colleagues can truly thrive. Support and continuous education is reinforced through partnerships with organisations such as Stonewall.
With a strong focus on building a sustainable future for its workforce and local communities, Binding Site has high aspirations for continuous improvement and ensuring their people contribute to their future vision. In addition, Binding Site has recently been recognised at the 2021 Birmingham Post Business Awards, winning both “Company of the Year” and “International Trade and Export” Awards.
Working at Binding Site means being part of a global, award-winning community that delivers innovative solutions with shared ideas and a collective dedication to improving patient lives, worldwide.
Location: Birmingham
Hours: 40 hrs Hybrid working with Birmingham Office base 3 days per week
Benefits:
- Competitive Salary
- Contributory Pension
- Life Assurance
- 25 days paid holiday plus bank holidays
- Medicash Wellbeing health benefit
- Salary Sacrifice cycle to work & electric car schemes.
PERSON SPECIFICATION