Clinical Development Manager

Job title:

Clinical Development Manager

Company

GlaxoSmithKline

Job description

The Clinical Development Manager (CDM) will be responsible for leading cross-functional teams in delivering quality clinical studies and/or tissue bank studies within the CUC with end-to-end involvement and oversight from protocol development, study set up, study execution, study closeout and final study report.The role is based within GSK’s Phase 1 Clinical Pharmacology Unit (Clinical Unit Cambridge).You will collaborate with other functions both within the CUC and wider GSK departments, as well as third parties external to GSK.We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.Discover more about our company wide benefits and life at GSK on our webpageIn this role you will

• Lead the operational delivery and quality of clinical trials and/or tissue bank studies within the CUC, ensuring compliance with ICH/GCP, regulatory, ethical requirements, and GSK written standards.
• Maintaining end-to-end oversight of study conduct and communications, including risk and issue management to make decisions which balance benefit/risk with a clear understanding of impact on project; takes actions to mitigate risk where appropriate.
• Developing, reviewing and/or enhancing the operational and scientific robustness of clinical trial documentation including Study Delivery Plans, Study Protocols and manuals, Informed Consent Forms, clinical study timelines, costing templates, and other study documents as required.
• Coordinating and submitting the required package of regulatory documents for approvals to conduct the clinical trial, e.g. Ethics Committee and Regulatory Clinical Trial Applications (CTAs), NHS R&D, and manage subsequent correspondence, approvals and amendments through to close-out of the clinical trial.
• Maintaining study documentation for the Investigator Site File for monitoring and inspection-readiness.
• Requires active partnership building and collaboration with other functions both within the CUC and wider GSK. Interact effectively across boundaries with functions using influencing and relationship-building skills.
• Managing and leading on multiple workstreams, alongside clinical trial management, and delivering to demanding deadlines.

Why you?Basic Qualifications & Skills:We are looking for professionals with these required skills to achieve our goals:

• Bachelor of Science or equivalent, or professional qualification in a life science field.
• Experience of successfully leading on clinical study delivery as a study manager, clinical development associate, clinical trial coordinator or other similar role within a Clinical Pharmacology Unit.
• Able to demonstrate understanding of the drug development process, with particular expertise in early clinical development, clinical trials requirements and clinical trial terminology.
• Experience working within a GCP environment (or similar).

Preferred Qualifications & Skills:Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

• Excellent organisation and leadership skills in a matrix team environment.
• Ability to deliver to demanding deadlines, with an agile and flexible approach, whilst maintaining quality.
• Exemplary written and verbal communication.
• Able to build relationships in a dynamic and matrix environment, including navigating, influencing and communicating complex discussions and issues, encouraging alternative perspectives, managing change, and developing solutions.

Closing Date for Applications – 08 Nov 2024 (COB)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.At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We’re uniting science, technology and talent to get ahead of disease together.Find out more:.Why GSK?Uniting science, technology and talent to get ahead of disease together.GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.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 neurodiversity, 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.Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on or 0808 234 4391.Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the and scroll to the Careers Section where you will find answers to multiple questions we receiveAs 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.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting site.

Expected salary

Location

Cambridgeshire

Job date

Sat, 02 Nov 2024 23:55:40 GMT

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