AstraZeneca Pharmaceuticals LP Local Study Team Leader in Wilmington, Delaware
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. As a Clinical Operations Lead, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.
Main Duties and Responsibilities
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 QA.
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.
Minimum Requirements and Preferred Background
Minimum Bachelor's degree (preferred in biological science or healthcare-related field)
Minimum of 3 years of 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 Functional 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 Management/PM Skills