Clinical Development Manager - open to flexible working
Clinical Development Manager - open to flexible working
At GSK, two opportunities have arisen within the Global Clinical Sciences & Data (GCSD) organisation to join us as Clinical Development Manager. This group provides operational support to clinical studies which evaluate a range of new chemical entities and new formulations in a wide variety of patient populations to support a broad range of indications.
Our compound aligned global teams focus on the development of medicines from Phase 1 though Proof of Concept to drug submission. We deliver Phase 2-4 studies in a timely and efficient manner ensuring studies are conducted in accordance with ICH GCP and GSK standards. Both positions are with the late phase team primarily working on HIV assets in partnership with ViiV Healthcare.
If you are an experienced and innovative Clinical Development Manager, you have the ability to perform the role of Operations and Science Lead (OSL) to deliver end to end study scientific and operational excellence, from concept to publication/submission and archiving, working in partnership with the cross functional study team then this role is definitely for you!
Knowledge and experience of Infectious Diseases/HIV is preferred but not essential.
- Leadership role in global strategic level projects, systems and or processes spanning Study Management/clinical operations and/or having significant impact across Medicine Development or across other R&D directorates including ViiV Healthcare
- Leads operational deliverables for at least two global studies and/or one project at any point in time (inhouse or outsourced to a CRO).
- Drives assessment, selection, engagement, training and management of appropriate vendors for outsourced clinical activities/services, ensuring compliance with GSK standards.
- Manages feasibility and determines global study allocation to appropriate countries and sites, ensuring efficient use of resources and adherence to company policies and strategic initiatives.
- Develops and maintains the global study budget, ensuring cost effectiveness and addressing and escalating issues as appropriate.
- Ensures set up and maintenance of all systems in order to plan and implement the study and track progress.
- Engagement with the study matrix team to ensure adoption and implementation of any new processes and systems to deliver the study
- Ensures appropriate clinical trial supply strategy is implemented and managed.
- Develops recruitment plan, manages risk, monitors progress, and implements contingencies as required.
- Ensures efficient streamlined processes are in place to deliver study to plan and ensure safety of patients and completeness/integrity of data.
- Ensures adherence to Good Clinical Practice and all applicable local and international regulations.
- Accountable for timely delivery of scientifically and operationally robust study documents.
- In partnership with the cross functional study team, develops a focused study protocol that meets scientific objectives and can be implemented in the clinical and regulatory environment of all participating regions to provide quality data and ensure timely study delivery.
- Ensures development, review, finalisation and delivery of high quality key clinical study documents in order to meet study timelines.
- Ensures accurate maintenance and archiving of study records including eTMF.
- Accountable for clinical vendor selection and contractual agreements, and ensures global feasibility of contractual agreements
- Accountable for site and monitor training in operational aspects of the study.
- Ensures a Lessons Learned meeting takes place, captures and shares cross functional study team practices.
- Ensures continuous direct contact with in-country personnel to provide ongoing operational support.
- Accountable for study related communications and for resolution or escalation of operational issues, and develops study communication plan to ensure efficient and appropriate global communication to all internal and external stakeholders
- Ensures processes are in place to address or escalate study issues as they arise.
Please make sure to apply before the 31st of August 2018!
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 the course of 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 requirements 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.
Ever wondered what is like to work at GSK?
- BSc. degree in Life Sciences, Public Health or other related discipline with extensive clinical development experience.
- A background in clinical development sciences at a CRO, pharmaceutical company or other medical environment with demonstrated leadership experience.
- Significant track record of global study management planning and delivery
- Scientific/therapeutic expertise in Infectious Diseases preferred. Proven expertise in the proactive identification of complex issues which may impact clinical programmes coupled with the ability to contribute to solutions affecting cross-functional matrix teams
- A demonstrated ability to plan, organise and manage resources to bring to successful completion specific study and objectives in accordance with defined quality and time-based metrics
- Expertise in the identification, evaluation and selection of key global preferred provider partnerships and demonstrated expertise in working with 3rd party suppliers
- Proven strong leadership skills
- Good communication and presentation skills
- Excellent influencing and negotiation skills
- Demonstrated success and ability to achieve results in a complex matrix environment
- Experience in external stakeholder/partner relationship management and communication
- Experience of working at a CRO or managing studies outsourced to CROs.
GSK is a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. Our products are used by millions of people around the world, helping them to do more, feel better and live longer. Employing over 100,000 people globally, we have 71 manufacturing sites around the world.
You may apply for this position online by selecting the Apply now button.
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