Short role description

This role holder is accountable for delivering the committed project management work of Oncology and Immune Oncology(ONCO & IO) 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.

This role is accountable for line managing a dedicated group of staff in ONCO & IO project management and project support team. As a member of Development Operations leadership team, he/she is accountable for planning and utilization of staff resources, assigned budget, objective setting and performance follow-up.

Typical Accountabilities

• Ensures adequate resources for the ONCO & IO studies in project management and supporting working
• Ensures that the workload of the team(s) is adequate.
• Development and performance management of the team(s).
• Ensures that everyone in the team has development and training plans, according to IDP process.
• Coaches the team members and all direct reports on a regular basis, and plans/organises coaching with external providers if needed.
• Contributes to high quality feasibility work.
• Oversees successful delivery of study delivery at country level targets to plan, with speed and quality
• Contributes to the quality improvement of the study processes and procedures.
• Ensures all systems are continuously updated.
• Ensures “Inspection Ready” at country and site level
• Assists Local Study Managers in forecasting study timelines, resources, recruitment, study materials and medication
• Provides direction to LSM on major study commitments resolving any key issues identified.
• Ensures collaboration with cross functional team and stakeholders.
• Ensures that study activities at country level comply with local policies and code of ethics.

Education, Qualifications, Skills and Experience

Essential

• Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification (*).
• Minimum 10 years of experience in Development Operations (CRA/LSM/ADSMM) or other related fields.
• Previous line management experience (preferably >3 years).
• Proven team building and people/organizational development skills.
• 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.
• Excellent organisational, analytical, influencing and negotiation skills.
• Excellent presentation and communication skills, verbal and written.
• Excellent decision-making skills.
• Excellent team building skills also in cross-functional teams.
• Excellent resource management skills.
• Good financial management skills.
• Excellent ability to have attention to details and combining with delegation and prioritisation skills.
• 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

• Very good knowledge of the Clinical Study Process, Procedural Documents and international ICH-GCP guidelines.
• Excellent knowledge of project management
• Good understanding of the Study Drug Handling Process and the Data Management Process. 
• Good knowledge of relevant local regulations.
• Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
• 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 conflict management skills and ability to handle crisis.
• Good interviewing skills – responsibility for attracting, developing and retaining personnel.
• Good intercultural awareness.
• Excellent ability to work according to global standards.
• Manager of manager experience

Key stakeholders and relationships

Internal (to AZ or team)

• Direct and indirect reporting staff
• R&D China leadership team members
• Clinical Feasibility and Recruitment Group
• Global Study Teams
• Therapeutic Area DCDs and ADCDs
• Quality Assurance
• Local HRBP
• Local Finance BP
• Medical Director
• Medical Affairs
• Local Marketing Company personnel including Patient Safety, Regulatory Affairs, Legal, Compliance, Finance, etc.

External (to AZ)

• Investigators and site personnel
• EC/IRB and Regulatory Authorities
• Local Pharma Associations and other relevant associations/authorities
• Study related vendors
• CROs (Staff vendors)

Date Posted

Closing Date

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.