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), LSTL is expected to perform site monitoring if needed. As part of the flexible capacity model it is expected that LSTL manages both roles.
LSTL is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.
* Overall responsibility for the study commitments within the country, for timely delivery of data to required quality as per SMA.
* Lead Local Study Team(s) consisting of monitors and study administrator(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 and to update other study team members on study matters
* Lead development of Local Monitoring Plan as per Targeted Monitoring guidance from respective Study Team.
* 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 monitor(s)
* 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.
* Contribute to patient recruitment strategy including regular communication with concerned Investigators as necessary.
* Communicate and co-ordinate regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters.
* Coordinate the process for selection of potential Investigators considering capability, competence, etc, of the Hospitals/sites.
* Plan and lead national Investigator meetings, in line with local codes
* Assist in forecasting study timelines, resources, recruitment, budget, study materials and drugs.
* Work in close coordination with Study Drug Coordinator to create a robust Drug Consumption Plan.
* Ensure timely preparation of country SMA, fSMA and Master CSA.
* Ensure completeness of the Study Master File and ensure essential documents are sent to SMO/Hub location/site.
* Ensure local Serious Adverse Event (SAE) reconciliation takes place.
* Facilitate translation of documents (ICFs, patient diaries, participation cards, etc) through external providers.
* Ensure timely submission of proper application/documents to EC/IRB.
* Work together with Regulatory Affairs to ensure timely delivery of proper application/documents for submissions to Regulatory Authority.
* Set up and maintain the study in IMPACT at study country level.
* Ensure accurate payments related to the study are performed.
* 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 Study Master File.
* Plan and lead activities associated with audits and regulatory inspections in liaison with Clinical Process Manager and CA&A.
* Provide input to process development and improvement.
* Provide regular information to Line Managers (SMM Director/CRM) at country level on study/ies and planned study milestones/key issues.
* Update Line Managers (SMM Director/CRM) about the performance of the monitors/CRAs.
* Ensure that study activities at country level comply with local policies & code of conduct.
* For CRA work, see CRA Job Description
* Assist Line Managers (SMM Director/CRM) in efficient functioning of the department at country level.
* Prepare and maintain study budget at country level in ACCORD.
* Liaise with Local Compliance Officer regarding payments to Investigators to ensure these are in accordance with local requirements.
* Timely preparation and support to process of registration of applicable clinical studies in country-specific or regional websites.
* Ensure that clinical and operational feasibility assessment of Study Design Concept and Clinical Study Protocol is performed to highest quality.
* Keep track on research intelligence in local markets.
* Support SMM region in initiatives/activities as agreed with Line Manager (SMM Director/CRM).
Minimum Requirements and Preferred Background
* Minimum University degree and / or equivalent, preferred 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.
* Good ability to learn and to adapt to work with IT systems.
Competencies and Skills
* Excellent knowledge of relevant AZ Procedural Documents.
* Excellent knowledge of international guidelines - ICH/GCP.
* Good knowledge of relevant local regulations.
* Good medical knowledge in relevant AZ Therapeutic Areas.
* Good understanding of the Drug Development Process.
* Good knowledge in Clinical Operations.
* Excellent understanding of the Clinical Study Process.
* Excellent knowledge/experience of the Monitoring Process.
* Good understanding of the Study Drug Handling Process.
* Good understanding of the Data Management Process.
* Good resource management skills.
* Good financial management skills.
* Good decision-making skills.
* Basic change management skills.
* Good delegation skills.
* Basic coaching skills.
* Basic ability in handling crisis situations.
* Excellent project management skills.
* Excellent team building skills.
* Excellent interpersonal skills.
* Good intercultural awareness.
* Excellent organisational skills.
* Good analytical skills.
* Good negotiation skills.
* Excellent communication skills, verbal and written.
* Excellent presentation skills.
* Excellent ability to prioritize and handle multiple tasks.
* Excellent ability to have attention to details.
* Good ability in working according to global standards.
Leadership Capabilities, Level 2
* Passion for Customers
* Thinks Strategically
* Acts Decisively
* Drives Performance
* Works Collaboratively
* Develops People and Organization
Deadline: 20 December 2013