Local Study Associate Director - Oncology

Short role description

To lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with AZ Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.

In addition to leading LST(s), the Local Study Associate Director (LSAD) may perform site monitoring as needed to support the flexible capacity model.

The LSAD is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.

LSADs s might have different internal titles based on the experience level (LSAD, Senior LSAD). The experience level depends on the years of experience, performance record, level of independence in the role, ability to take on additional tasks or tutor more junior colleagues. The Director, Country Head Senior Director, Country Head may assign this internal title after confirmation with Senior Director, Cluster Head / Executive Director, Regional Head.

Typical Accountabilities

• Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.

• Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies • Leads and optimises the performance of the Local Study Team(s) at country level ensuring compliance with AZ Procedural Documents, ICH-GCP and local regulations.

• Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.

• Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.

• Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.

• Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in AZ clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head.

• Ensures timely preparation of local Master CSA (including site budget) and amendments as needed .

• Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant AZ SOPs and local regulations.

• Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sitesready to enrol, and in line with AZ SOPs.

• Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction).

• Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.

• Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.

• Reviews monitoring visit reports (as required and following AZ SOPs) and pro-actively advices the monitor(s) on study related matters.

• Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.

• Proactively identifies risks and facilitates resolution of complex study problems and issues.

• Organises regular Local Study Team meetings on an agenda driven basis.

• Actively works towards achieving good personal relationships with all Local Study Team members, sites’ staff and global stakeholders.

• Reports study progress/update to the Global Study Associate Director/ Global Study Team including SMM Lead.

• Contributes to patient recruitment strategy including regular communication with participating Investigators as necessary.

• Develops, maintains and reviews risk management plan on country study level: proactively manages sites, stakeholders, local and global vendors and customers to ensure risks are timely identified, mitigated and managed.

• Communicates and co-ordinates regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters, if applicable.

• Plans and leads National Investigator meetings, in line with local codes, as required.

• Assists in forecasting study timelines, resources, recruitment, budget, study materials and drug supplies.

• Ensures relevant systems required to facilitate business critical, license to operate activities (for example, Safety Reporting, Regulatory submissions, Clinical Trial Transparency) are set-up, updated and access is organised at country level.

• Ensures accurate payments related to the study are performed according to local regulations and agreements.

• Participates in training and coaching new members of the Local Study Team ensuring compliance with ICH-GCP and AZ Procedural Documents.

• Ensures completeness of the eTMF and ensures essential documents are uploaded in a timeline manner to maintain the eTMF “Inspection Ready”.

• Ensures that all study documents are ready for final archiving and completion of local part of the eTMF.

• Plans and leads activities associated with audits and regulatory inspections in liaison with CQAD and QA.

• Provides input to process development and improvement.

• Provides regular information to Line Managers at country level on study/ies and planned study milestones/key issues.

• Updates Line Managers about the performance of the CRAs/CSAs.

• Ensures that study activities at country level comply with local policies and code of ethics.

• Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.

• Ensures compliance with AstraZeneca’s Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).

• Collaborates with local Medical Affairs team. • Supports SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management.

• Ensures that all study documents are ready for final archiving and completion of local part of the eTMF.

• Plans and leads activities associated with audits and regulatory inspections in liaison with CQAD and QA.

• Provides input to process development and improvement.

• Provides regular information to Line Managers at country level on study/ies and planned study milestones/key issues.

• Updates Line Managers about the performance of the CRAs/CSAs.

• Ensures that study activities at country level comply with local policies and code of ethics.

• Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.

• Ensures compliance with AstraZeneca’s Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).

• Collaborates with local Medical Affairs team.

• Supports SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management.

People Management

Responsibility

Direct reports: I

indirect reports Approximate number 0

• Individual contributor (specialist)
• Matrix Manager (projects/dotted line) X
• Manager of a team Grandfather (manager of a manager)

Span of Influence

(how many countries will the role have mandate to assign work to and take decisions on)

Operates in:

• Own country (or another country (small clusters)) X
• 2 or 3 countries
• Global

Education, Qualifications,

Skills and Experience

Essential

• Bachelor degree in related discipline, preferably in life science, or equivalent qualification (*). • Minimum 3 years of experience in Development Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies).

• Good knowledge of international guidelines ICHGCP as well as relevant local regulations.

• Proven ability to lead and motivate crossfunctional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.

• Excellent project management skills.

• Excellent team building and interpersonal skills.

• Excellent organisational skills.

• Excellent verbal and written communication skills.

• Excellent ability to prioritize and handle multiple tasks.

• Excellent attention to details.

• Excellent knowledge of spoken and written English.

• Good negotiation skills. •

Good ability to learn and to adapt to work with IT systems.

• Ability to travel nationally and internationally as required.

Desirable

•  Cell Therapy experience at least 3 years

•   Hematology experience at least 5 years

•   Therapeutic area expertise in Cell Therapy including CAR-T, Apheresis, Tissue, Hematology and Cell banks.

•   Clinical project manager/Country study manager/Clinical Trial

• Manager/Clinica Research Manager/ Local Trial Manager/Clinical Operations/ Local Study Associated Director experience at least 5 years

•   English C1

•   Tactical awareness

• Superior communication and networking skills across cultures and countries

• Extraordinary resilience

•   Exceptional team player

•  Audacious vision and proactivity

•   High level of negotiation skills

•   Flexibility in a very changeable environment

•   Ability to work independently

•   Contribute to build Cell therapy strategy

•   Flexibility in travels for onsite engagement

• Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.

• Good knowledge of the Drug Development Process.

• Excellent understanding of the Clinical Study Process including monitoring.

• Very good understanding of the Study Drug Handling Process and the Data Management Process.

• Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.

• Integrity and high ethical standards.

• Good analytical skills. • Good resource management skills.

• Good decision making and delegation skills.

• Good financial management skills.

• Basic change management skills.

• Basic coaching skills

. • Basic ability in handling crisis situations

. • Good intercultural awareness

Key stakeholders and relationships

Internal (to AZ or team)

• Local Study Team

• Global Study Team including SMM Lead (STOM)

• Line manager/ local SMM LT team

• Clinical Quality Associate Director

• Local Medical Teams: Medical Affairs and MSLs

• Local Regulatory Affairs

• Local Patient Safety

External (to AZ)

• Investigators and site personnel

• EC/IRB • CRO (staff vendors)

• Study related vendors

• Inspectors

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.