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Director, Site Management & Monitoring (Clinical Research)
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Full-time
bachelor degree
Posted 41d ago
~40 hrs/week
Responsibilities
Oversee the delivery of clinical research study targets at the country level while managing the performance and development of direct reports. Ensure study activities comply with local policies and maintain inspection-ready electronic Trial Master Files (eTMF).
Requirements
Requires a university degree in a healthcare-related field and at least 5 years of experience in clinical research, preferably in oncology. Candidates must possess strong project management skills, a valid driving license, and the ability to travel.
Full job description
At AstraZeneca, we unlock the power of what science can do. Empowered to explore, everyday we work towards our ultimate aim – treating, preventing, modifying and even curing complex diseases.
With an unwavering belief in following the science, we unleash our curiosity. Investing in key areas, harnessing innovative technologies and taking smart risks. Help to shape the future of healthcare as we take our pipeline from strength to strength.
Embrace an environment built on lifelong learning. Never complacent, we seek opportunities to expand our knowledge. The place to build a long-term meaningful career.
Here we get to develop and grow – whether that’s working at the leading-edge or on varied stages and molecules. Working on things that have never been done before.
In return, when great science comes alive, we have the opportunity to get published.
We stand together behind a shared ambition. United by our collective passion for having a positive impact on patients’ lives. Important work that is both meaningful and fulfilling. With the potential to reach over a billion patients across the globe who are living with these complex diseases.
Background & Qualifications
University degree, preferably from healthcare related areas (Pharmacy, Veterinary, Chemistry, Biology, Medical etc. Faculties),
Advanced level of English,
Minimum 5 years of experience in clinical research field preferably in oncology (CRA / Sr. CRA / LSAD/ADCR/LM) or other related fields if experience is adequate.
Minimum 2 years experience for Local Study Manager position in Oncology area, preferably
Line Management experience, preferably
Proven project management experience
Excellent presentation and communication skills, verbal and written.
Excellent organisational, analytical, influencing and negotiation skills.
Ability to prioritize and handle multiple tasks,
Basic coaching skills and good at team work,
Financial management skills,
Effective planning and organizational skills with result-oriented approach,
Stakeholder management experience,
Analytical thinking, critical reasoning ability,
Good command of MS Office applications,
No restriction to travel,
Driving License,
No military obligation for male candidates.
Summary Job Description
Manage change with a positive approach for self, team and business. Sees change as an opportunity to improve performance and add value to business.
Ensures adequate resources for the studies assigned.
Development and performance management of direct reports.
Ensures that direct reports have development and training plans, according to IDP process.
Coaches the direct reports on a regular basis, and plans/organizes coaching with external providers if needed.
Contributes to efficient Clinical Research Department organization and its functioning at country level by working closely with responsible Director, Oncology Country Head, Clinical Research Department.
Contributes to high quality feasibility work.
Oversees successful delivery of Clinical Research study delivery country level targets to plan, with speed and quality.
Contributes to the quality improvement of the study processes and other procedures.
Ensures all systems are continuously updated.
Ensures completeness and timeliness of the eTMF to maintain it “Inspection Ready”.
Assists Director, Oncology Country Head, Clinical Research Department or Local Study Associate Directors /CRAs/teams in forecasting study timelines, resources, recruitment, study materials and drugs.
Provides direction to LSADs/teams on major study commitments including resolving any key issues identified.
Supports Clinical Research Department region in initiatives/activities as agreed with Director, Oncology Country Head, Clinical Research Department.
Ensures collaboration with local Medical Affairs team.
Ensures that study activities at country level comply with local policies and code of ethics.
Reviews SQV reports of direct reports in line with AZ SOPs
Reviews Accompanied site visits/co- monitoring visits/training visits/QC visits performed to direct reports in line with the local QC plans.
Performs accompanied site visits/co-monitoring visits/training visits/QC visits according to local QC Plan, supporting ongoing coaching and development.
Why AstraZeneca?
A high performing team, we work hard to not just meet but go beyond the needs of patients and the wider healthcare industry We leverage our partnerships with external experts across the industry, to create and communicate evidence that changes medical practice. As a partner for many, we effectively communicate complex ideas whilst seeking to understand ever-changing needs and requirements. Our valuable contribution and scientific expertise is responsible for advancing our pipeline and accelerating our pathway to finding a cure.
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
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 authorization and employment eligibility verification requirements.
We're transforming the future of healthcare by unlocking the power of what science can do for people, society and the planet. For more information, visit www.astrazeneca.com.
Community Guidelines: bit.ly/2MgAcio
Offices: 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, Cambridgeshire CB2 0AA, GB · Astraallen, Sodertalje, Stockholm County 152 57, SE
PharmaceuticalBiopharmaceuticalInnovationResearch and developmentand Global businessHealth CareBiopharmaBiotechnologyMedicalPrecision Medicine
We're transforming the future of healthcare by unlocking the power of what science can do for people, society and the planet. For more information, visit www.astrazeneca.com.
Community Guidelines: bit.ly/2MgAcio
Offices: 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, Cambridgeshire CB2 0AA, GB · Astraallen, Sodertalje, Stockholm County 152 57, SE
PharmaceuticalBiopharmaceuticalInnovationResearch and developmentand Global businessHealth CareBiopharmaBiotechnologyMedicalPrecision Medicine