Director, BioPharma Site Management and Monitoring 2 year FTC
Luton, UK
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.
The Director Site Management & Monitoring (DSMM) is accountable for delivering the UK commitments for BioPharma clinical interventional studies under their supervision according to agreed resources, budget and timelines complying with AZ Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. DSMM role is TA aligned, the current vacancy will be responsible for studies in immunology and specialty indications including establishing key relationships with partner sites and KEEs.
The DSMM is accountable for ensuring that study sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.
The DSMM is responsible for line managing dedicated group(s) of staff, covering planning and utilization of staff resources, assigned budget, objective setting, monitoring and performance follow-up.
Vaccine and Immune systems study experience would be advantageous.
Typical Accountabilities:
Leadership of dedicated group, building the team spirit, developing team style and behaviour, promoting inclusion and diversity.
Ensures adequate resources for the studies assigned.
Ensures that the workload of direct reports is appropriate.
Development and performance support of AZ direct reports, including coaching and mentoring.
Prepares salary and bonus proposals for direct reports based on their performance in close collaboration with Senior Director, BP Country Head and local HRBP.
Contributes to efficient SMM organisation and its functioning at country level by working closely with Senior Director, BP Country Head.
Oversees successful delivery of SMM study delivery country level targets to plan, with speed and quality.
Contributes to the quality improvement of the study processes and other procedures.
Ensures completeness and timeliness of the eTMF to maintain Inspection Readiness.
Provides direction to Local Study Teams on major study commitments including resolving any key issues identified
Supports SMM region in initiatives/activities as agreed with Senior Director, BP Country Head.
Ensures collaboration with local Medical Affairs team in strategy and delivery for given TA.
Ensures that study activities at country level comply with local policies and code of ethics.
Supports Quality Manager in oversight of Country Quality Management Plans.
Essential criteria:
Bachelor degree in related discipline, preferably in life science, or equivalent qualification
Relevant years of experience in Development Operations (CRA / SrCRA / Project Manager) or other related fields
Line Management experience.
Excellent interpersonal skills
Manage change with a positive approach for self, team and business. Sees change as an opportunity to improve performance and add value to business
Proven management experience
Excellent organisational, analytical, influencing and negotiation skills
Excellent presentation and communication skills, verbal and written
Excellent knowledge of spoken and written English
Good ability to learn and to adapt to work with IT systems
Ability for national and international travel.
Desirable criteria:
Established knowledge of the Clinical Study Process and international ICH-GCP guidelines
Knowledge of the risk-based Monitoring Process.
Good understanding of the Study Drug Handling Process and the Data Management Process.
Good knowledge of relevant local and international regulations.
Good knowledge and ability to learn relevant AZ Therapeutic Areas.
Ability to deliver quality according to the requested standards.
Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
Ability to work in an environment of remote collaborators.
Integrity and high ethical standards.
Resource management skills.
Decision-making skills.
Financial management skills.
Ability to manage conflict.
Interviewing skills – responsibility for attracting, developing and retaining personnel.
Excellent team building skills also in cross-functional teams.
Good intercultural awareness.
Ability to work according to global standards.
Why AstraZeneca
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 until the 6th February 2023.
Where can I find out more?
Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
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Date Posted
26-Jan-2023Closing Date
06-Feb-2023AstraZeneca 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 authorization and employment eligibility verification requirements.