JOB DESCRIPTION
Your main responsibilities:
- Reviewing study outlines/synopses from a medical perspective and assessing the feasibility of conducting the proposed studies in Cromos Pharma countries.
- Recommending countries for study execution.
- Participating in the development of feasibility questionnaires.
- Coordinating feasibility assessments until the project is handed over to Clinical Operations.
- Providing ongoing support for feasibility activities upon request after the handover to Clinical Operations.
- Communicating with key opinion leaders (KOLs) and principal investigators (PIs).
- Coordinating the negotiation and execution of confidentiality agreements (CDAs) and feasibility questionnaires with potential vendors, sites, and PIs, ensuring smooth communication and continuity.
- Conducting analytical reviews and preparing feasibility assessment reports.
- Collaborating with the business development team when preparing commercial proposals.
- Coordinating responses to client inquiries regarding country selection and enrollment projections, and facilitating further interactions with clients after proposals are submitted.
- Reviewing proposals.
- Participating in meetings related to commercial proposals.
- Assisting in preparing RFPs, managing the investigator grant calculator, and preparing key feasibility indicators for budget proposals.
- Collaborating with other departments to ensure high-quality feasibility assessments and the rapid initiation of clinical trials globally.
- Regularly reviewing and complying with Standard Operating Procedures (SOPs) and Work Instructions (WIs), updating training records, and ensuring timely completion of timesheets.
You have:
- A diploma or master’s degree in nursing, biological sciences, or medical sciences;
- An equivalent combination of education, professional training, and experience is also acceptable.
- Minimum of 4 years of experience in clinical research.
- At least 1 year of experience in a similar field.
- Knowledge of ICH-GCP and national regulations related to clinical research.
- Understanding of the feasibility assessment process.
- Knowledge of clinical trial processes related to trial initiation and medical terminology.
- Excellent verbal and written communication skills in English.
- Strong organizational skills, document management, decision-making, customer service, and interpersonal communication.
- A strong team player with a focus on teamwork, ability to manage the team.
- Analytical mindset.
- Proficient in PC use, including Microsoft Office, Excel, etc.
- Regular training in different therapeutic areas to carry out feasibility assessments.
We offer:
- Career opportunities at local, regional and global levels;
- Support for personal and professional development;
- Competitive salary;
- Annual bonuses and perks;
- Work from home option.
We provide equal opportunity to all qualified applicants and employees by prohibiting discrimination in employment decisions because of race, color, religion, sex, national origin, age, veteran status or disability.
If you are ready to start your journey at Cromos Pharma, please send your CV to cv@cromospharma.com.