Clinical Development Manager, Open to flexible working

Location
Addenbrookes, Cambridgeshire
Salary
£Competitive
Posted
13 Jan 2021
Closes
31 Jan 2021
Ref
274518
Contract Type
Permanent

In this role you will be responsible for leading a cross functional GSK Clinical Unit Cambridge study team in the delivery of quality multiple clinical studies conducted within the Clinical Unit Cambridge (CUC), with end to end involvement from protocol development to study execution and final study report.

These roles are above clinic, they are focused on the organisational set up, operational management and oversight responsibilities. You may also be required, by Global Clinical Study Delivery (GCSD), Clinical Operations to act as a Study Delivery Lead (SDL) for selected GSK studies.

Key Responsibilities include, but are not limited to:

  • Execute, supervise or coordinate the required applications for approvals (IRAS, adoption to NIHR portfolio, ethics, NHS R&D, ARSAC etc) of designated studies
  • Using expertise in experimental medicine and clinical pharmacology studies to support the design and execution of experimental clinical studies across GSK.
  • Leading operational excellence in study conduct, ensuring successful execution of study set-up, study procedures and key negotiations with vendors and strategic partners.
  • Managing, maintaining and track the portfolio of studies placed at the Clinical Unit Cambridge as proposed, planned, initiated and completed.
  • Leading activities around patient involvement in clinical research in line with GSK's "Focus on the Patient" initiatives and processes.
  • Connecting with the institutes in and around Cambridge/London and in the experimental medicine network to set up collaborative experimental medicine projects.

Please take a copy of the Job Description, as this will not be available post closure of the advert.

When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

During your application, you will be requested to complete voluntary information, which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirement's, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.

Basic Qualifications:

  • Bachelor of Science or equivalent, or professional qualification in a life science field.
  • General understanding of the pharmaceutical industry and the clinical development process.
  • Ability to develop high quality clinical protocols (or equivalent types of documents).
  • In depth practical knowledge of study delivery and data management.
  • Knowledge of HTA, ICH GCP, GMP and GxP requirements, regulatory and ethical requirements, SOPs and policies.
  • Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrix environment.
  • Some expertise in the proactive identification of issues which may impact clinical programs coupled with the ability to contribute to solutions affecting cross-functional matrix teams.

Preferred Qualifications:

  • Advanced degree (e.g. MS, PhD, PharmD) or equivalent experience.

Why GSK?

At GSK, we're a company with a special purpose, to help people do more feel better and live longer. Realising our purpose starts with us. When we feel at our best, we perform at our best.

When you set out on your adventure at GSK, we make a deal. You commit to living GSK's values and expectations and performing against our Innovation, Performance and Trust priorities. And in return, GSK commits to providing the right environment for you to thrive. Put simply, it's about you being motivated to do your best work, in a place where you can be you, feel good and keep growing.

Together we build an environment where we can all thrive and focus on what matters most to each of us. It is only through the energy, dedication, drive and passion of all of us that we can be the very best for GSK, and importantly, for our patients and consumers.

As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Please don't hesitate to contact us if you'd like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities. 

As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

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