Clinical Trial Manager at InDex Pharmaceuticals
At InDex we are working to improve the treatment of ulcerative colitis with our proprietary drug candidate cobitolimod. Take the opportunity and join this growing company at a good time!
As Clinical Trial Manager you will be responsible for the planning, execution and reporting of current and future trials within the phase 3 program for cobitolimod and you will be the primary contact to the CRO. This is an important role and you will be part of a dedicated team. The role is full-time, with flexibility of mixing in-office and remote working. The office is based in the middle of the Karolinska Institutet area.
As the Clinical Trial Manager, you will:
- Plan, lead and report clinical trials at InDex
- Monitor trial progress to ensure compliance with trial protocol, project plan and to identify areas of concern to evaluate and resolve or escalate
- Act as point of contact to the CRO, develop and maintain good working relationships
- Ensure that the program meets all ICH/GCP Guidelines and is inspection ready
- Write, contribute to, or review clinical trial protocols and other clinical research related documents
- Manage the budget and contract with the CRO
- Review data management compliance activities including data quality and integrity
- Support and maintain relationships with Key Opinion Leaders, Investigators and Advisors
- Support the design, implementation and evaluation of recruitment strategies for the clinical trials
- Prepare reports on clinical trial progress, enrollment trends and appropriate recommendations
Education and experience
- A Bachelor’s degree or equivalent in Life Sciences as a minimum
- At least 8 years experience as a Clinical Trial Lead for late-stage clinical trials
- Management of global clinical trials and demonstrated professional knowledge of regulatory requirements, ICH/GCP and management of CROs
- Previous experience of clinical trials in the gastroenterology therapy area is a plus
- Excellent oral and written communication skills in English
- Self-motivated and able to work independently and have strong organizational skills
- High standards for quality
- Ability and drive to deliver on goals, objectives and timelines
- Influential & assertive communication skills
- Problem solving skills
- People management skills
Position Type/Expected Hours of Work
- This is a full-time position with flexibility of mixing in-office and remote working.
- Travel is expected for e.g. site visits and conferences
Is this a job for you? Please, send your CV and a personal letter to [email protected].
We will do rolling interviews, so apply as soon as possible and no later than November 25, 2022.
For further questions regarding the position, feel free to contact Eva Arlander (Chief Development Officer): +46 702-556855
Recruitment agencies, please don’t make contact.
InDex Pharmaceuticals in brief
InDex is a pharmaceutical development company focusing on immunological diseases where there is a high unmet medical need for new treatment options. The company’s lead asset is the drug candidate cobitolimod, which is being evaluated in the phase III study CONCLUDE as a novel treatment of moderate to severe ulcerative colitis – a debilitating, chronic inflammation of the large intestine. InDex has also developed a platform of patent protected discovery stage substances, so called DNA based ImmunoModulatory Sequences (DIMS), with the potential to be used in the treatment of various immunological diseases.
InDex is based in Stockholm, Sweden. The company’s shares (ticker INDEX) are traded on Nasdaq First North Growth Market Stockholm. For more information, please visit www.indexpharma.com.