Director, Site Management and Monitoring (DSMM)
- Recruiter
- AstraZeneca
- Location
-
Luton
East of EnglandUnited Kingdom
- Salary
- Competitive
- Posted
- 16 Oct 2021
- Closes
- 25 Oct 2021
- Job Title
- Associate Director
- Category
- Scientific and Pharmaceutical
- Contract Type
- Permanent
- Hours
- Full Time
*Director, Site Management and Monitoring (DSMM)*
*Horizon Place, Luton*
*Competitive salary and benefits*
*Bring out the best in each other, and yourself, by working together as one*
In our dynamic environment, be supported by the brightest minds working together side by side. Agile and collaborative, we work cross–functionally, as well as externally, to thrive at pace.
Embrace an environment built on lifelong learning. Never complacent, we seek opportunities to expand our knowledge and deliver our studies to the highest quality.
You'll provide technical leadership either as an experienced lead or through leadership of small to medium sized clinical studies to ensure effective collaboration between the project teams. You will develop and build, or act as an expert within a cross–functional multi–skilled team comprised of specialists across a range of products within AstraZeneca to drive continuous improvement.
We are looking for an experienced line manager to join our teams based in Luton and play a key role in enabling the delivery across all UK studies in our BioPharma portfolio delivering the committed part of all clinical interventional studies under their supervision. It's important that we do this according to agreed resources, budget and timelines through aligning with AZ Procedural Documents, international and local guidelines such as ICH–GCP as well as relevant local regulations.
You will be responsible for leading a mixed your team of clinical research specialists, providing line management through coaching and performance development, oversight of study and personal objectives and responsible for planning and utilization of staff resources across BioPharma. , working to and following up on allocated budget.
It is also expected that the DSMM would be involved in non–project work and potentially contribute to regional/global work tasks and initiatives as appropriate.
You would be directly supporting Local Study Teams in oversight of quality and delivery performance across our studies from start–up through to site close out and document archiving.
This is a full–time office–based role in Luton. We would consider this position initially as a secondment opportunity for an internal employee.
*Responsibilities*
You will lead a mixed team of 10–12 staff comprising both AZ and contractor CRAs, Local Study leaders and Clinical Study Administrators, all locally based in the UK. You will oversee their workloads, performance and help your AZ team develop and grow, providing mentorship, coaching and effective leadership.
A key part of this role is to ensure successful delivery of our BioPharma studies through meeting our targets with speed and quality, you will be involved in:
* Ensuring adequate resources are assigned for each study
* Working closely with responsible Country Head of SMM and cross functionally with other teams within and external to AZ
* Contributing to high quality feasibility work, and quality improvement of the study processes and other procedures.
* Leading by example in making sure all systems are continuously updated, including completeness and timeliness of the eTMF to maintain "Inspection Readiness".
* Assisting Country Head or Local Study leaders/teams in forecasting study timelines, resources, recruitment, study materials and drug.
* Providing direction to Local Study leaders/teams on major study commitments including resolving any key issues identified.
* Ensuring that study activities at country level comply with local policies and code of ethics.
* Providing oversight of monitoring reports of direct reports ensuring compliance with AZ SOPs
* Performing CRA accompanied site visits/co– monitoring visits/training visits/QC visits as required in line with the local QC plans.
To succeed in this role, you will have a strong background in Development Clinical Operations (CRA / Sr. CRA / LSM) or other related fields. You will also have experience of developing and managing teams, helping to empower them to do their best work.
*You will also have:*
* Bachelor's degree in related subject area, preferably in life science, or equivalent qualification.
* Excellent presentation and communication skills, verbal and written.
* Demonstrated ability to lead change with a positive approach for self, team and business seeing change as an opportunity to improve performance and add value to business.
* Proven project management experience.
* Excellent organisational, analytical, influencing and negotiation skills.
* Ability for travel when needed which will be occasional, and mostly national.
At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.
This role is open from 8 October until 22 October 2021.
*Where can I find out more?*
Follow AstraZeneca on LinkedIn []()
Follow AstraZeneca on Facebook []()
Follow AstraZeneca on Instagram []()
*Horizon Place, Luton*
*Competitive salary and benefits*
*Bring out the best in each other, and yourself, by working together as one*
In our dynamic environment, be supported by the brightest minds working together side by side. Agile and collaborative, we work cross–functionally, as well as externally, to thrive at pace.
Embrace an environment built on lifelong learning. Never complacent, we seek opportunities to expand our knowledge and deliver our studies to the highest quality.
You'll provide technical leadership either as an experienced lead or through leadership of small to medium sized clinical studies to ensure effective collaboration between the project teams. You will develop and build, or act as an expert within a cross–functional multi–skilled team comprised of specialists across a range of products within AstraZeneca to drive continuous improvement.
We are looking for an experienced line manager to join our teams based in Luton and play a key role in enabling the delivery across all UK studies in our BioPharma portfolio delivering the committed part of all clinical interventional studies under their supervision. It's important that we do this according to agreed resources, budget and timelines through aligning with AZ Procedural Documents, international and local guidelines such as ICH–GCP as well as relevant local regulations.
You will be responsible for leading a mixed your team of clinical research specialists, providing line management through coaching and performance development, oversight of study and personal objectives and responsible for planning and utilization of staff resources across BioPharma. , working to and following up on allocated budget.
It is also expected that the DSMM would be involved in non–project work and potentially contribute to regional/global work tasks and initiatives as appropriate.
You would be directly supporting Local Study Teams in oversight of quality and delivery performance across our studies from start–up through to site close out and document archiving.
This is a full–time office–based role in Luton. We would consider this position initially as a secondment opportunity for an internal employee.
*Responsibilities*
You will lead a mixed team of 10–12 staff comprising both AZ and contractor CRAs, Local Study leaders and Clinical Study Administrators, all locally based in the UK. You will oversee their workloads, performance and help your AZ team develop and grow, providing mentorship, coaching and effective leadership.
A key part of this role is to ensure successful delivery of our BioPharma studies through meeting our targets with speed and quality, you will be involved in:
* Ensuring adequate resources are assigned for each study
* Working closely with responsible Country Head of SMM and cross functionally with other teams within and external to AZ
* Contributing to high quality feasibility work, and quality improvement of the study processes and other procedures.
* Leading by example in making sure all systems are continuously updated, including completeness and timeliness of the eTMF to maintain "Inspection Readiness".
* Assisting Country Head or Local Study leaders/teams in forecasting study timelines, resources, recruitment, study materials and drug.
* Providing direction to Local Study leaders/teams on major study commitments including resolving any key issues identified.
* Ensuring that study activities at country level comply with local policies and code of ethics.
* Providing oversight of monitoring reports of direct reports ensuring compliance with AZ SOPs
* Performing CRA accompanied site visits/co– monitoring visits/training visits/QC visits as required in line with the local QC plans.
To succeed in this role, you will have a strong background in Development Clinical Operations (CRA / Sr. CRA / LSM) or other related fields. You will also have experience of developing and managing teams, helping to empower them to do their best work.
*You will also have:*
* Bachelor's degree in related subject area, preferably in life science, or equivalent qualification.
* Excellent presentation and communication skills, verbal and written.
* Demonstrated ability to lead change with a positive approach for self, team and business seeing change as an opportunity to improve performance and add value to business.
* Proven project management experience.
* Excellent organisational, analytical, influencing and negotiation skills.
* Ability for travel when needed which will be occasional, and mostly national.
At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.
This role is open from 8 October until 22 October 2021.
*Where can I find out more?*
Follow AstraZeneca on LinkedIn []()
Follow AstraZeneca on Facebook []()
Follow AstraZeneca on Instagram []()