We are currently hiring.
Indigo is today seeking a
Clinical Affairs Manager,collaborating directly with the CMO, to manage the strategy, design, planning, implementation, execution, coordination and overall direction of Indigo’s clinical research and studies. You will interact with all clinical study sites and various internal/external stakeholders in Europe and USA and successfully deliver Indigo’s clinical research studies world-wide, in compliance with regulations and company SOP’s.
Your main responsibilities and opportunities
- Lead and manage Indigo’s clinical strategy in collaboration with global Key Opinion Leaders (KOLs).
- Develop and design clinical study protocols and compile clinical evidence.
- Lead the development, writing and reviewing of clinical study documents (including protocols, reports and investigator brochure) and manuals in compliance with the applicable European MDR and US FDA regulations and ICH-GCP requirements.
- Participate in the feasibility assessments and evaluation of investigative sites.
- Administer and supervise trial implementation including preparation/submission of Ethics Committee/Institutional Review Board materials and MoH submissions.
- Identify, qualify, select and manage vendors and contractors to ensure quality and continuity of the clinical studies.
- Supervise preparation and execution of site staff training including Indigo’s SOP´s, preparation/maintenance of study documents, completion of forms, understanding of examinations/assessments required.
- Manage clinical sites independently under minimal supervision and direction, to ensure successful execution of clinical study projects.
- Establish and manage detailed study budget over the entire course of the studies.
- Provide leadership and guidance on issues where cross functional/BU consistency is essential for good clinical practice.
- Assist in preparation of clinical data presentations for regulatory submissions, conferences and study meetings.
- Lead the writing of white papers based on clinical data collected and facilitate publications where appropriate.
- Doctor of Medicine or Master’s degree in biological and/or clinical science or Master’s degree in Biomedical Engineering, or an equivalence by experience. A specialisation in endocrinology is a plus.
- 5 years of relevant experience in project management within clinical research (preferentially as Clinical Study Manager) in a CRO, pharmaceutical, biotechnology or medical technology company is a plus.
- Knowledge of FDA and EU standards and guidance on clinical studies.
- Self-starter requiring minimal supervision, hands-on with a strong ‘can-do’ attitude.
- Independent judgment skills & action orientation for obtaining required results.
- Excellent oral and written English communication skills – fluent both in general and subject-matter related technical vocabulary.
- You are accurate, diplomatic, and you have an eye for details.
- Willingness to travel – about 20%.
- You are a team player, excited to join a world-class team and get the finest job on earth.
What we offer
Indigo is your unique opportunity to expand yourself as an experienced Clinical Affairs manager, actively shaping the design and conduct of global clinical projects in a young, dynamic and fast-growing company. Together with Indigo’s international team of experts, you will contribute to bringing our cutting-edge solution to the market and return to people with diabetes and their loved-ones the control of their life.
We offer a competitive salary, freedom to work independently, a fun-loving and high-performing team and the opportunity to work on one of the defining technologies for the coming decade in diabetes management.
Join us today!
Send us your motivation letter and CV (HR@indigomed.com)
We look forward to hearing from you!