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), LSM is expected to perform site monitoring if needed. As part of the flexible capacity model it is expected that a LSM manages both roles.

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

A LSM with > 5 years’ experience, good performance record and that works independently in his/her role and with ability to take on additional tasks and/or tutor more junior colleagues may be entitled Senior LSM. The local SMM Country Head may assign seniority after confirmation with Cluster/Regional Director.

Typical Accountabilities

• Overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
• Lead Local Study Team(s) consisting of CRAs, CSA(s).
• Lead and optimise the performance of the local Study Team(s) at country level ensuring compliance with AZ Procedural Documents, ICH-GCP and local regulations.
• Coordinate the site selection process by identifying potential sites/investigators, perform initial Site Quality Risk Assessment, conduct Site Qualification Visits to evaluate suitability and quality risk.
• LSM oversees, manages and coordinates monitoring activities from site activation through study closure at country and site level in accordance with the Monitoring Plans.
• Contribute to review of monitoring visit reports and pro-actively advice the monitor(s) on study related matters.
• Perform any required co-monitoring & QC visits with study CRAs.
• Proactively identify and facilitate resolution of complex study problems and issues.
• Organise regular Local Study Team meetings on an agenda driven basis.
• Actively work towards achieving good personal relationships with all Local Study Team members.
• Report study progress/update to the SMO Study Leader/Team including SMM STOM Lead.
• Contribute to patient recruitment strategy including regular communication with concerned Investigators as necessary.
• Risk management plan: Proactive management of sites, implement action plans for non-recruiting sites.
• Communicate and co-ordinate regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters.
• Plan and lead national Investigator meetings, in line with local codes.
• Assist in forecasting study timelines, resources, recruitment, budget, study materials and drugs.
•  Plan and coordinate applicable local drug activities (from local purchase or reimbursement to drug destruction).
• Ensure timely preparation of country fSMA and maintain accurate study budget in ACCORD.
• Ensure timely preparation of National/ local Master CSA and amendments as needed.
• Ensure all country and site level trial essential documents required by ICH GCP prior to study start have been collected and verified for correctness to achieve sites ready to enrol.
• Ensure completeness of the eTMF and ensure essential documents are uploaded in a timeline manner to maintain the eTMF “inspection Ready”.
• Ensure 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.
• Ensure timely submission of proper application/documents to EC/IRB during the duration of the study.
• Work together with Regulatory Affairs to ensure timely delivery of proper application/documents for submissions to Regulatory Authority during the duration of the study.
• Set up and maintain the study in CTMS/ IMPACT at study country level as well as local websites as required by local laws and regulations.
• Ensure accurate payments related to the study are performed according to local regulations.
• Participate in training and coaching new members of the Local Study Team ensuring compliance with ICH/GCP and AZ Procedural Documents.
• Ensure that all study documents are ready for final archiving and sign-off completion of local part of the eTMF.
• Plan and lead activities associated with audits and regulatory inspections in liaison with CQM and QA.
• Provide input to process development and improvement.
• Provide regular information to Line Managers (SMM CH/ADs) at country level on study/ies and planned study milestones/key issues.
• Update Line Managers (SMM CH/ADS) about the performance of the CRAs/CSAs.
• Ensure that study activities at country level comply with local policies & code of ethics.
• As delegated ensure that clinical and operational feasibility assessment of Study Design Concept and Clinical Study Protocol is performed to the highest quality.
• Provide feedback to keep track on research intelligence in local markets.
• Ensure compliance with AstraZeneca’s Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
• Collaborate with local MSLs in clinical study support.
• Support SM&M in different initiatives as agreed with SMM CH/CD.
• For CRA work, see CRA Job Description

Education, Qualifications, Skills and Experience

Essential

• Minimum University degree preferably in biological science or healthcare-related field.
• Minimum 3 years’ experience in Clinical Operations or other related fields (Medical Affairs-led studies or Academic-led studies)
• Excellent knowledge of spoken and written English.
• Minimum of 5-6 years’ experience as CRA
• Experience in clinical trials coordination (local study leader) will be highly valued
• Experience in Oncology clinical trials will be highly value
• Good ability to learn and to adapt to work with IT systems.
• Proven ability to lead and motivate cross-functional teams to deliver clinical trials according to or ahead of time plan, budget and with maintained quality.

Desirable

• Good knowledge of international guidelines - ICH/GCP as well as relevant local regulations.
• Good medical knowledge in relevant AZ Therapeutic Areas.
• Good understanding of the Drug Development and Handling Process.
• Good knowledge in Clinical Operations.
• Excellent understanding of the Clinical Study Process including monitoring and local data management handling.
•  Good resource and finance management skills.
• Good decision and delegation skills.
• Basic change management skills.
• Basic coaching skills.
• Basic ability in handling crisis situations.
• Excellent project management skills.
• Excellent team building and interpersonal skills.
• Good intercultural awareness.
• Excellent organisational skills.
• Good analytical skills.
• Good negotiation skills.
• Excellent communication skills, verbal and written.
• Excellent ability to prioritize and handle multiple tasks.
• Excellent ability to have attention to details.
• Good ability in working according to global standards.
• Ability to travel nationally and occasional international travel

Key Relationship

Internal

• Local study team
• Global study team including SMM STOM Lead
• Line manager/ local SMM LT team
• Clinical Quality Manager
• Local Medical Teams: Med Affairs and MSLs
• Reg. Affairs
• Patient Safety

External

• Investigators and site personnel
• EC/IRB
• CRO (staff vendors)
• Study related vendors
• Inspectors

Date Posted

28-abr.-2021

Closing Date

19-may.-2021

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.