Local Study Manager

The Nordic Site Management & Monitoring (SMM) team is on a constant 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 and every person counts. Are you seeing opportunities in change and get motivated by trying new ways? Welcome to join our journey!

We are recruiting for two Local Study Managers (LSM) - one within Oncology and one within Respiratory and CV. This is a position with responsibility for leading and optimizing 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. Our LSM team work flexible with base in Gärtuna, Södertälje in Sweden.

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.

What you will do:
As Local Study Manager (LSM) you are responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived. In addition to leading LST(s), the LSM may perform occasional site monitoring as needed to support the flexible capacity model. Be overall responsible for the study commitments within the Nordic countries and for timely delivery of data to required quality.

Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality. Assure timely submission of application/documents to EC/IRB at start up and for the duration of the study and 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. Other responsibilities;

* 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).
* Reports study progress/update to the Global Study Leader/ Global Study Team including SMM Lead.
* 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.

Essential requirements:

* 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, as well as the Study Drug Handling Process and the Data Management Process.

As we work in global cross-functional teams, you should have excellent collaboration and communication skills to work effectively with geographically dispersed colleagues. You need to be able to work independently, analytically and take initiative with the ability to prioritize and handle multiple tasks. You also need to have shown project management and organizational skills, as well as team building skills with the ability to mentor and coach.

Your interpersonal skills are important and we see the successful candidate as motivated, goal-oriented with a problem-solving attitude. This together with high ethical standards and good intercultural awareness. Ability to travel nationally and internationally is required.

If this sounds like your next career opportunity - apply now!

We look forward to your application no later than 13th December.

For more information about the position please contact hiring manager Anna Koch, anna.koch@astrazeneca.com