Clinical Trials Consultants

Job description
Are you an expert in clinical trials and looking for a new opportunity? Perhaps, you are in the beginning of your career and curios to learn more about clinical trials? Regardless of your answer, we have two open positions for you!

For consultant assignments within the clinical trials in drug development, we are now looking for a senior clinical trials manager and a junior clinical trials associate. You will have a key role in conducting phase I, II and III clinical trials for pharmaceuticals. In the role as a clinical trial manager, you will lead and be responsible for the trials. As a clinical trial associate, you will support and collaborate closely with the clinical trial manager and other colleagues in your team. 
For both positions, you have the opportunity to work remotely. 

Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.

Responsibilities
As clinical trial manager, you will lead clinical trials in phase I, II and III. Initially, you will lead a phase II trial. As clinical trial associate, you will support the clinical trial manager and other team members to complete the trial. For both roles you will provide operational input for study documents, such as synopsis, protocol, ICF, CRFs, CRF completion guidelines, study plans, laboratory manual, study reference manual, pharmacy manual, clinical data review plan, clinical database specifications development, clinical study report (CSR) development, etc.

Main responsibilities clinical trial manager
Lead phase II trial and the trials cross-functional global team
Collaborate with, and manage, the CRO functional teams to deliver on time, within budget and with quality.
Manage vendor oversight for additional third-party vendors, including laboratories, IXRS, EDC, ePRO and central imaging, as needed.
Maintain and provide information for monthly study status and risks/mitigation strategies (including enrollment curves and timelines) for reporting to senior management. 


Main responsibilities clinical trial associate
Support clinical trial manager in managing the CRO functional teams to deliver on time, within budget and with quality.
Support clinical trial manager in managing countries/regions for site activation, CRA and site support during study maintenance, conduct sponsor quality monitoring/oversight visits to sites and/or CRAs performance assessment in adherence to GCP as needed, and support the study close-out and database lock activities.
Perform co-monitoring
Participate in study data review


Qualifications
For both roles, you hold a M.Sc. or B.Sc. and/or relevant field. You have excellent communication skills, are collaborative and can manage multiple projects. You have an ability to research, compile information, and review data. You are fluent in English and knowledge in Swedish is a plus. Finally, you should be able to work independently and have a positive, goal oriented and problem-solving attitude. For the clinical trial manager you have excellent leadership skills.

Qualifications clinical trial manager
Minimum 3-5 years clinical trial management experience in biotech/pharma/CRO
Working knowledge of GCP, ICH and FDA regulations
Strong study management track record showing clear proficiency in clinical project management, including vendor management
Experience interfacing with key medical personnel at clinical site(s)
Prior monitoring of clinical trial sites
Familiarity with clinical data management, DSMB and biostatistics/programming processes preferred


Qualifications clinical trial associate
Minimum 1-3 years clinical trial management experience in biotech/pharma/CRO
Working knowledge of GCP, ICH and FDA regulations
Demonstrated detailed understanding of clinical protocol and intended study populations, as well as solid overall drug development




Application
2022-04-30, selection and interviews will be ongoing. The positions may be filled before the last day of application, therefore, apply as soon as possible.
For more information, please contact Linda Inge linda.inge@randstad.se. 
For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

About the company
Randstad Life Sciences specializes in the field of science and is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus!