Local Study Associate Director (LSAD) Sweden
Posted Oct 28, 2021
We are excited to be expanding our team and looking for an experienced, highly motivated Local Study Manager who shares our passion for ensuring our customer's clinical trials will be handled with care and expertise.
TFS is a Global CRO headquartered in Sweden. We genuinely believe that "Global in mind and local at heart" is the core of our success; we operate in a global environment while retaining an in-depth knowledge of regulatory requirements in every country where we operate.
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), the Local Study Manager (LSM) may perform site monitoring as needed to support the flexible capacity model.
LSM is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.
LSMs might have different internal titles based on the experience level (Associate LSM, LSM, Senior LSM). The experience level depends on the years of experience, performance record, level of independence in the role, ability to take on additional tasks or tutor more junior colleagues. The CH SMM/CD SMM may assign this internal title after confirmation with Cluster Director SMM/Senior Director SMM (Region).
These internal tiered titles will only be applicable for countries which have been exempted to use tiered internal titles.
- Bachelors 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).
- 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 trials according to or ahead of time plan, budget and with required quality.
- Excellent project management skills.
- Excellent team building and interpersonal skills.
- Excellent organisational skills.
- Excellent verbal and written communication skills.
- Excellent ability to prioritize and handle multiple tasks.
- Excellent attention to details.
- Excellent knowledge of spoken and written English.
- Good negotiation skills.
- Good ability to learn and to adapt to work with IT systems.
- Ability to travel nationally and internationally as required.
Mid-Senior levelApply for this job