Local Study Manager - ONCOLOGY

Location: Field based

Salary: Competitive and benefits

At AstraZeneca, we believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us.

To lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines aligning with AstraZeneca Procedural Documents, international guidelines such as ICH-GCP including relevant local regulations.

In addition to leading LST(s), the Local Study Manager (LSM) may perform 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.

Responsibilities

• Has the overall responsibility for the study commitments within the country and for timely delivery of data to required standard and quality

• 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 (fSMA) and maintains accurate study budget in AZ clinical studies financial system by regular checks of the system and financial reports (as agreed with ADSMM/CH).

• 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.

• Oversees, leads and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans, including performing any required co-monitoring, Accompanied Site Visits/training visits with study CRAs. Reviews monitoring visit reports and pro-actively advices the monitor(s) on study related matters

• Supports SMM in different initiatives (local, regional or global) as agreed with the CH/CD SMM.

Essential requirements

• Good knowledge of international guidelines ICH-GCP as well as relevant local regulations.

• Significant experience with Oncology clinical studies and knowledge of the Oncology therapeutic area

• Capability to lead and motivate cross-functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.

• Excellent team building and interpersonal skills.

• Organisational ned negotiation skills

• Good ability to learn and to adapt to work with IT systems.

• Ability to travel nationally and internationally as required.

Desirable

• Medical knowledge and ability to learn relevant AZ Therapeutic Areas.

• Knowledge of the Drug Development Process.

• Understanding of the Clinical Study Process including monitoring.

• Understanding of the Study Drug Handling Process and the Data Management Process.

Education

• Bachelors degree in related discipline, preferably in life science, or equivalent qualification.

• Relevant experience in Development Operations (CRA, Sr CRA) or other related fields (Medical Affairs-led or Academic-led studies).

Date Posted

Closing Date

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.