Job Description: Clinical Trial Manager - Gastroenterology Focus (IBD & Crohn's)
Position: Clinical Trial Manager
Location: Spain (Emerging Region)
Employment Type: Full-Time
Industry: Clinical Research, Gastroenterology
Overview:
We are seeking an experienced Clinical Trial Manager with expertise in gastroenterology, specifically Inflammatory Bowel Disease (IBD) and Crohn's disease, to lead and oversee the successful initiation and execution of six new clinical trials in an emerging Spanish region. This is a unique opportunity to shape groundbreaking research while contributing to advancements in treatment for IBD and Crohn's disease.
Key Responsibilities:
1. Trial Leadership:
Plan, execute, and manage six concurrent clinical trials in gastroenterology, focusing on IBD and Crohn's disease. Ensure trials adhere to regulatory requirements, company SOPs, and Good Clinical Practice (GCP) guidelines.
2. Team Coordination:
Lead and mentor cross-functional teams, including Clinical Research Associates (CRAs), site staff, and data managers. Collaborate with global stakeholders, principal investigators, and key opinion leaders.
3. Site Management:
Oversee site selection, initiation, and monitoring to ensure compliance and operational excellence. Build and maintain relationships with local research sites and healthcare professionals in the Spanish region.
4. Regulatory Compliance:
Develop and submit regulatory documents, ethics committee applications, and trial master files. Monitor adherence to Spanish and international clinical trial regulations.
5. Budget and Timeline Management:
Manage trial budgets, timelines, and resources to meet project goals. Anticipate and mitigate risks to ensure smooth trial progression.
6. Data Integrity:
Ensure robust data collection, monitoring, and reporting practices are followed across all trials. Work closely with data management and biostatistics teams for high-quality deliverables.
Required Qualifications:
1. Education: Bachelor's or advanced degree in life sciences, healthcare, or a related field.
2. Experience:
o 5+ years of experience in clinical trial management.
o Proven expertise in gastroenterology, particularly IBD and Crohn's disease.
o Demonstrated success managing multiple clinical trials simultaneously.
3. Skills:
o Strong leadership, organizational, and problem-solving abilities.
o Excellent knowledge of GCP, ICH guidelines, and Spanish clinical trial regulations.
o Proficiency in Spanish and English (both written and verbal).
o Familiarity with emerging clinical research regions is a plus.
Preferred Qualifications:
1. Prior experience with innovative trial designs or emerging therapies in gastroenterology.
2. Strong network within the Spanish medical and clinical research community.
What We Offer:
1. A dynamic and collaborative work environment in an emerging clinical research market.
2. Opportunities to contribute to cutting-edge treatments for IBD and Crohn's disease.
3. Competitive salary, benefits, and opportunities for professional development.
4. The chance to make a meaningful impact in patients' lives through groundbreaking research.
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