Line Manager Study Support - Site Management and Monitoring
Manager Study Support -Site Management and Monitoring
To lead, develop and provide direction to US Site Management and Monitoring localpersonnel to enable delivery of local drug studies and non-drug projects by providing expertise (project, TA scientific, technical and operational knowledge). To work collaboratively across US SM&M to manage and coordinate SM&M resources within SM&M, thus ensuring optimal resource utilization and consistency of the site management and monitoring capabilities. To work in collaboration with the Associate Directorsin SM&Mregarding resourcing in support of delivery of local clinical studies from feasibility to CSR and study closed and archived. The role holder will also be responsible for embedding consistent ways of working across SM&M and building the site management and monitoring capabilities
What you’ll do
- Provide appropriately skilled Site Management and Monitoring personnel to local study delivery teams to ensure delivery of clinical studies to time, budget and quality through an integrated skill set model in accordance with clinical performance targets
- Works with Associate Directors within US SM&M to support Capacity Management, achieve accurate resource forecasting, analysis and solution building to efficiently and flexibly resource local study teams
- Provide expertise and direction to support direct reports with proactive problem/risk identification, solution building and issues resolution to facilitate achievement of objectives on time and to appropriate quality.
- Ensure that the workload of the team(s) or direct reports is adequate
- Development and performance management of the team(s) or direct reports
- Ensure that everyone on the team or direct reports have development and training plans, according to IDP process
- Ensure training plans/trainings are completed via SABA within required 30-day certification timelines.
- Ensure that the individual performance planning and review process is completed for all direct reports
- Prepare salary and bonus proposals of all team members or direct reports based on their performance in close collaboration with responsible Associates Director SMM and HR partner.
- Ensure all systems are continuously updated.
- Oversight of support systems and personnel (vendors) managing processs of data input: (TMF, Impact, Angel, iBUY, ISF, ISL distribution, record management).
- Contribute to the quality improvement of the study processes and other procedures.
- Plan and organise coaching of the team members and all direct reports
- Act as first-line support for GCP and AZ processes
- Promote and encourage innovation and creativity by bringing suggestions/good examples to SM&M leadership
- Provide skills development and create opportunities for staff within the projects, drug and non-drug projects.
- Contribute to the business through drug/non-drug project or departmental activities.
- Lead and support change by encouraging diversity of solutions that are value demonstrated
- Promote and encourage communication within and across SM&M.
- Role model and embed performance driven culture.
- Recruit and retain Site Management and Monitoring personnel.
- Ensure compliance to ethics, policies and standard procedures
Essential for the role
- Bachelor’s degree required, preferably in medical or biological science, or related subject or equivalent qualifications or experience.
- Five or more years of experience in the pharmaceutical industry working with delivery of clinical studies
- Line management experience
- An understanding of the therapeutic areas related to AstraZeneca’s products
- Comprehensive knowledge of clinical and pharmaceutical drug development process
Desirable for the role
- Ability to work in an environment of remote collaborators.
- Proven leadership promoting motivation and empowerment of others in order to accomplish individual, team and organisational objectives
- Manages change with a positive approach to the challenges of change for self, team and the business.
- Sees change as an opportunity to improve performance and add value to the business
- Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
- Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills
- Good problem solving and conflict resolution skills
- Demonstrated ability to set and manage priorities, resources, performance targets and project
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.