Associate Director Clinical Research - Bangalore/Mumbai/Delhi
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
Typical Accountabilities :
Leadership of dedicated group, building the team spirit, developing team style and behavior.
Ensures adequate resources for the studies assigned.
Ensures that the workload of direct reports is adequate.
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.
Prepares salary and bonus proposals for direct reports based on their performance in close collaboration with responsible (Senior) Director, Country Head and local HRBP.
Contributes to efficient SMM organization and its functioning at country level by working closely with responsible (Senior) Director, Country Head.
Contributes to high quality feasibility work.
Supports 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 all systems are continuously updated.
Ensures completeness and timeliness of the eTMF to maintain it “Inspection Ready”.
Provides direction to CRAs and CSAs on major study commitments including resolving any key issues identified.
Ensures that study activities at country level comply with local policies and code of ethics.
Reviews monitoring visitreports 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 according to local QC Plan, supporting ongoing coaching and development.Ongoing communication with Functional Service Providers, including directions and feedback on insourced/outsourced work
Essential
Bachelor degree in related discipline, preferably in life science, or equivalent qualification.
A minimum of 8 years in global clinical operations within a multinational pharmaceutical company or Contract Research Organization (CRO).
Experience must include direct clinical site monitoring for global phase 2/3 studies and
Proven track record in leading a team of Clinical Research Associates (CRAs) or managing global phase 2/3 studies.
Strong inclination towards people leadership, performance management, and talent development.
Minimum 4years of experience in Development Operations (CRA / Sr CRA / LSAD) or other related fields.
Strong scientific understanding of therapeutic areas, drug development processes, and Good Clinical Practice (GCP).
Must be qualified as a physician, pharmacist, dentist, or nurse.
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.
Project management experience.
Excellent organizational, 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 travel, if applicable.
Desirable
Good knowledge of the Clinical Study Process. And international ICH-GCP guidelines.
Excellent knowledge of the Monitoring Process.
Good understanding of the Study Drug Handling Process and the Data Management Process.
Good knowledge of relevant local and international regulations.
Good medical 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.
Good resource management skills.
Excellent decision-making skills.
Good conflict management skills and ability to handle crisis.
Good interviewing skills – responsibility for attracting, developing and retaining personnel.
Excellent team building skills.
Good intercultural awareness.
Excellent ability towork 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, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.
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.
