Clinical Development and Operations is the most important part of growing biotechs. It is the difference between helping millions of people on time or making them wait years.
The FDA / EMA and people across the world rely on how safe and how robust clinical trials are conducted. Our client is relying on you to support their Onco- Hematology platform.
Their key molecule, which is used to cure certain cancers, such as mantle cell lymphoma, chronic lymphocytic leukemia, and Waldenstrom's macroglobulinemia, has helped 135.000 patients around the world.
With more than 130 ongoing clinical trials worldwide, this company is dramatically changing people's lives.
If you would like to join their mission and to work alongside some of the best medical experts and scientists then continue reading.
As an Associate Study Manager you will be responsible for;
* Significant work with all Clinical Operations areas ( I-III ) with a focus in patient safety, trial design, site activation and documentation.
* Responsible for budget maintenance and allocating funds according to research results, strategy and company decisions
* With the team select and engage key clinical study sites/centers and establish and maintain collaborative relationships with key investigators.
* Ensure that Clinical Development Standard Operating Procedures (SOPs) facilitate the development of effective clinical study protocols and are compliant
* Develop/review/edit essential study documents such as protocols, medical monitoring plan, and medical data reviewing plan, case report forms, database specifications, and statistical analysis plan
* Provide medical input in all essential documents, including, investigator brochure, clinical study reports, IND and NDA summary documents safety annual reports
* Support clinical research development and implementation of the study protocols, clinical trials and start-ups all within the defined project scope, budget and timeline
* Provide clinical research data to support EMA / FDA and other regulatory bodies and communicate across Medical, Commercial and Quality teams.
As an Associate Study Manager you will need;
* Scientific Degree background
* Previous work within oncology and haematology
* Extensive work in clinical development and trial design.
* English fluent
* Preferred previous work in the clinics, ideally with cancer patients.
* Proven track record of most of the above job responsibilities or transferable experiences.
* Competitive salary.
* Flexible working.
* Friendly office space, coffee, tea, social events.
* Extensive Oncology and Haematology portfolio to work with including Immunotherapy,
* Housing and child support if needed. Group pension plan.
* Working with some of the newest oncology treatments in Europe.
* Empowering work space, offering opportunities to share ideas and influence company services development worldwide