Job summary
Our sponsored GI/Lymphoma cancer clinical research portfolio is both world-leading and practice changing. This is a unique opportunity to help develop, oversee and deliver an exciting portfolio and team dedicated to advancing clinical practice in GI/Lymphoma cancer.
Main duties of the job
This post is responsible for the development, oversight and delivery of the GI/Lymphoma portfolio managed within RM CTU.
There are three key domains to the post - project management, team management and portfolio management; in addition to corporate contribution.
The post-holder will project manage a number of complex Medicines and Healthcare products Regulatory Agency (MHRA) regulated clinical trials, ensuring that they are set-up, delivered, and closed-down in accordance with Good Clinical Practice (GCP) and all applicable regulations. The post therefore requires a clinical research professional with excellent project management skills and extensive experience of sponsor-level management of clinical trials in an academic environment.
The post-holder will establish, develop and manage a growing team of senior trial managers and data managers, each of which will work on their own portfolio of sponsored studies. The post will oversee the line management of these staff and prioritise and allocation workload to ensure effective and efficient trial management and delivery.
About us
The Royal Marsden NHS Foundation Trust is a world-leading cancer centre. Our role is to offer our patients the best cancer care available anywhere in the world, and to continue to make a global contribution to finding better ways of diagnosing and treating cancer. We employ over 4,500 staff in a diverse range of careers including nursing, medical, science, radiography, pharmacy, occupational therapy, finance and administrative services. We have two hospitals - one in Chelsea, London, and one in Sutton, Surrey - as well as a Medical Daycare Unit in Kingston Hospital.
At The Royal Marsden, we deal with cancer every day, so we understand how valuable life is. When people entrust their lives to us, they have the right to demand the very best. That's why the pursuit of excellence lies at the heart of everything we do.
At the heart of the hospital is our dedicated team. We offer a stimulating and dynamic working environment, a wide range of staff benefits, learning and development opportunities and clear career pathways. There are opportunities to work flexibly across a range of areas and specialities and we welcome flexible working requests from point of hire to support employees work life balance. We are looking for employees who aspire to excellence, share our values and can play a crucial role in our on-going achievements.
Job description
Job responsibilities
For further information on this role, please see the attached detailed Job Description and Person Specification
- Liaise closely with the CI, database programmer, statistician and other key members of the study team (i.e. clinical fellow) to ensure on-going clinical, scientific and operational oversight.
- Be a point of contact for participating sites, sponsor(s), funder(s), pharmaceutical partners, regulatory authorities and the trial oversight committees.
- Oversee the day-to-day conduct of the study at participating sites, providing support and advice and addressing any logistical issues as they arise.
- Organise regular meetings as needed to facilitate the efficient management of the clinical trial, preparing the agenda and meeting papers, and provide minutes following the meeting in a timely manner.
- Ensure timely data collection and receipt / transfer of any clinical materials or samples for clinical trials.
Job description
Job responsibilities
For further information on this role, please see the attached detailed Job Description and Person Specification
- Liaise closely with the CI, database programmer, statistician and other key members of the study team (i.e. clinical fellow) to ensure on-going clinical, scientific and operational oversight.
- Be a point of contact for participating sites, sponsor(s), funder(s), pharmaceutical partners, regulatory authorities and the trial oversight committees.
- Oversee the day-to-day conduct of the study at participating sites, providing support and advice and addressing any logistical issues as they arise.
- Organise regular meetings as needed to facilitate the efficient management of the clinical trial, preparing the agenda and meeting papers, and provide minutes following the meeting in a timely manner.
- Ensure timely data collection and receipt / transfer of any clinical materials or samples for clinical trials.
Person Specification
Education/Qualifications
Essential
- Educated to degree level (e.g. BA or BSc) or equivalent experience
- Good Clinical Practice certification
Desirable
- Higher degree qualification (e.g. MSc) in a relevant subject, preferably in the medical or biological sciences.
- Project management qualification (eg PRINCE 2).
Experience
Essential
- Extensive experience of the sponsor-level management of MHRA and HTA regulated clinical trials in an academic environment
- Experience of safety reporting to regulatory authorities.
- Experience of establishing, developing and managing a team.
- Experience of working across organisational boundaries with multidisciplinary teams
- Experience of developing systems and processes to allow efficient management and conduct of multi-centre clinical trials
- Experience of communicating effectively with all levels of staff - written and verbal
Desirable
- Experience of developing and implementing new SOPs and processes
- Experience of MHRA inspection.
Skills / knowledge
Essential
- Detailed knowledge of UK clinical trial regulations, GCP and regulatory frameworks.
- Knowledge of developing budgets for clinical trials and practical use of AcoRD
- A detailed understanding of the clinical trials approval process to conduct clinical research in the UK
- Knowledge of the requirements of clinical trials and clinical research projects during their life-cycle especially at the startup stage
- Proven problem solving skills.
- Excellent presentation skills
- Knowledge of clinical trial design issues in conducting oncology studies
- Proficient in the using PC based Windows and Microsoft Office software including the internet and e-mail.
Desirable
- Proficient in the using PC based Windows and Microsoft Office software including the internet and e-mail.
- Detailed knowledge of clinical trial methodology and /or statistical issues as they pertain to clinical trials.
- Excellent report writing skills
- Knowledge of Visio and or MS Project
Other requirements
Essential
- Ability to work in a proactive manner to identify new risks and issues and flag upwards appropriately
- Maintain a positive and enthusiastic attitude towards tasks and their goals.
- Ability to work well within a multi-disciplinary team environment in an effective and supportive way.
- Ability to work effectively to tight deadlines under direction and on own initiative.
- Able to work under pressure, methodical in approach, with effective problem-solving ability
- A high level of accuracy and attention to detail
- Ability to prioritise workload of others while balancing own workload(s).
- Flexible attitude and capable of dealing with changing working conditions.
- Able to work on both sites and to be flexible to meet the needs of the role
Desirable
- Clear understanding of and interest in GI & Lymphoma cancer research.
- Ability to negotiate, acting in a tactful and confident manner to achieve the desired results.
- Willing and able to coach and train others
Person Specification
Education/Qualifications
Essential
- Educated to degree level (e.g. BA or BSc) or equivalent experience
- Good Clinical Practice certification
Desirable
- Higher degree qualification (e.g. MSc) in a relevant subject, preferably in the medical or biological sciences.
- Project management qualification (eg PRINCE 2).
Experience
Essential
- Extensive experience of the sponsor-level management of MHRA and HTA regulated clinical trials in an academic environment
- Experience of safety reporting to regulatory authorities.
- Experience of establishing, developing and managing a team.
- Experience of working across organisational boundaries with multidisciplinary teams
- Experience of developing systems and processes to allow efficient management and conduct of multi-centre clinical trials
- Experience of communicating effectively with all levels of staff - written and verbal
Desirable
- Experience of developing and implementing new SOPs and processes
- Experience of MHRA inspection.
Skills / knowledge
Essential
- Detailed knowledge of UK clinical trial regulations, GCP and regulatory frameworks.
- Knowledge of developing budgets for clinical trials and practical use of AcoRD
- A detailed understanding of the clinical trials approval process to conduct clinical research in the UK
- Knowledge of the requirements of clinical trials and clinical research projects during their life-cycle especially at the startup stage
- Proven problem solving skills.
- Excellent presentation skills
- Knowledge of clinical trial design issues in conducting oncology studies
- Proficient in the using PC based Windows and Microsoft Office software including the internet and e-mail.
Desirable
- Proficient in the using PC based Windows and Microsoft Office software including the internet and e-mail.
- Detailed knowledge of clinical trial methodology and /or statistical issues as they pertain to clinical trials.
- Excellent report writing skills
- Knowledge of Visio and or MS Project
Other requirements
Essential
- Ability to work in a proactive manner to identify new risks and issues and flag upwards appropriately
- Maintain a positive and enthusiastic attitude towards tasks and their goals.
- Ability to work well within a multi-disciplinary team environment in an effective and supportive way.
- Ability to work effectively to tight deadlines under direction and on own initiative.
- Able to work under pressure, methodical in approach, with effective problem-solving ability
- A high level of accuracy and attention to detail
- Ability to prioritise workload of others while balancing own workload(s).
- Flexible attitude and capable of dealing with changing working conditions.
- Able to work on both sites and to be flexible to meet the needs of the role
Desirable
- Clear understanding of and interest in GI & Lymphoma cancer research.
- Ability to negotiate, acting in a tactful and confident manner to achieve the desired results.
- Willing and able to coach and train others
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
