Local Study Manager
SMM Nordic is part of the Development Operations in the global Research & Development (R&D) function. SMM executes and delivers clinical studies. Sweden contribute with a substantial part of the SMM Nordic delivery. Clinical studies are delivered in close collaboration with stakeholders in health care and academic medical institutions.
The LSM is responsible for leading the Local Study Team(s) (LSTs) at Nordic level to deliver committed components of global 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 Manager (LSM) may perform occasional site monitoring as needed to support the flexible capacity model. The LSM is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.
In the Nordic SMM team we have recently started a journey. We want to re-invent our organisation to find new and more effective ways of working in delivering our studies. We want each function to be accountable of their work and processes. Every person counts! Are you seeing opportunities in change and get motivated by trying new ways. We need you, come be a part of our journey!
Our LSM team work flexible with base in Gärtuna, Södertälje in Sweden.
- Overall responsibility for the study commitments within the Nordic countries 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 and maintains accurate study budget in AZ clinical studies financial system by regular checks of the system and financial reports
- Ensures timely preparation of local Master CSA (including site budget) and amendments as needed
- Ensures timely preparation of country level Master Informed Consent Form 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 sites ready 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 proactively advice 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
- 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 Leader/ 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 Coordinating 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
- Bachelor degree in related discipline, preferably in life science, or equivalent qualification
- Minimum 3 years of experience in Development Operations (CRA, Sr CRA) or other related fields (Medical Affairs-led or Academic-led studies)
- Very good knowledge of international guidelines ICH-GCP as well as relevant local regulations
- Proven ability to lead and motivate cross-functional teams to deliver clinical studies according to or ahead of time plan, budget and with required quality
- Excellent understanding of the Clinical Study Process including monitoring
- Very good understanding of the Study Drug Handling Process and the Data Management Process
- Integrity and high ethical standards
- Excellent project management skills
- Excellent team building and interpersonal skills
- Excellent organisational skills
- Excellent verbal and written communication skills (Swedish and English)
- Excellent ability to prioritize and handle multiple tasks
- Good negotiation skills
- 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
Ability to travel nationally and internationally as required.
If you are interested, please apply now!
For more information about the position please contact Anna Koch, email@example.com
Welcome with your application no later than June 2nd, 2019.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.