We are a passionate growing pharmaceutical company focusing on the development of new innovative therapies for the treatment of severe disorders that affect the central nervous system, such as Alzheimer’s disease and pain. We are now looking to extend our development team with a Clinical Trial Manager who will manage and coordinate clinical studies that we conduct. The role reports to the Chief Medical Officer.
The employment is a permanent employment with immediate access. The workplace is located at Karolinska University Hospital in Huddinge.
You are welcome to send an application with your CV, a brief description of your background, a rationale for why you are suited for this job and two reference persons by August 10 to email@example.com. You are welcome to contact us if you have specific questions, or visit our website www.alzecurepharma.com for general information about AlzeCure Pharma.
- 5 years or more of experience as a Clinical Trial/Project Manager in the pharma/ life science /biotech industry
- Preferably experience within Neurosciences (pain or Alzheimer studies)
- Extensive oversight experience
- Life science degree
- Motivates and ensures team effectiveness through eliciting feedback
- Excellent communication, presentation and problem-solving skills
- Budget and resource forecast skills
- Managing vendors/external service providers
- Good knowledge of GCP requirements
- Excellent written and oral communication skills in English
Being an integral part of a smaller innovative-driven organization, you will have the opportunity to interact and directly influence the future directions for our projects, and therefore:
- As a person you should be highly entrepreneurial, with a strong personal drive and a high level of accountability. A “can-do-attitude” focusing on actions not problems.
- Excellent problem solving
- Is curious, positive, pro-active and likes working in a fast-growing environment where functions and processes are still in development and enjoys contributing to building up the structures
- Is willing to travel occasionally
- Is willing to perform also CRA level duties
- Strong customer-oriented mindset
Duties & Responsibilities
- Lead and matrix manage the global multidisciplinary project team to ensure all project / trial deliverables are met according to timelines, budget, quality standards and operational procedures
- Identify sites and manage study set-up
- Lead the clinical trial protocol development process
- Responsible for ordering and management of clinical trial materials
- Support the CRAs on study related questions and serve as point of contact for managing/ answering questions relating to trial procedures and subject eligibility
- Responsible for set-up and maintenance of the Trial Master File for assigned studies
- Regularly update all trial information databases in order to manage accuracy of information
- Co-ordinate pre-audit activities for nominated projects
- Contribute to identification and evaluation of new centres suitable for performing TM studies in healthy volunteer and patients.
- Work closely with the external vendors – ensuring and maintaining high quality
- Document sponsor oversight
- Ensure that good quality management and monitoring systems are in place
- Review and approval of documentation (e.g. Monitoring Visit Reports, Data Management Plans, Safety Plan, Statistical Analysis Plans etc.)