Medical Monitor (Oncology Experience)

Ergomed

2+ years

Not Disclosed

Remote, USA

10 Nov. 25, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Company Description:
Ergomed Group is a rapidly expanding, full-service mid-sized CRO specializing in Oncology and Rare Diseases. Since its founding in 1997, the company has grown organically through strategic investments and landmark acquisitions, with operations in Europe, North America, and Asia.

At Ergomed, we prioritize employee visibility, encourage creative contribution, and provide realistic career development opportunities. Our company culture is truly international, and we are committed to fostering a supportive and inclusive environment. We value employee experience, well-being, and mental health, understanding that a healthy work-life balance is essential for both employee satisfaction and the delivery of high-quality client service.

Join us in our mission to make a positive impact on patients’ lives.

Job Description:
We are seeking a Senior Medical Director to lead our global medical function, including medical monitoring activities. This role will involve strategic planning, cross-functional communication, and participation in clients' decision-making processes. The Senior Medical Director will also provide leadership to the medical advisory and medical monitoring projects, ensuring they are compliant with federal regulations, ICH guidelines, GCP, and Ergomed’s Standard Operating Procedures (SOPs).

This position also involves mentoring and developing Ergomed physicians to become subject matter experts in medical monitoring. The Senior Medical Director will play an active role in monitoring project costs, deliverables, and overall performance, while working closely with project managers and the Head of Medical Affairs. Efficiency strategies will also be implemented, ensuring the highest quality standards are maintained.

Key Responsibilities:

Lead medical monitoring activities, including patient safety surveillance and data integrity.
Serve as the primary medical representative and point of contact for sponsors.
Coordinate and deliver training for Medical Monitors and oversee their activities.
Provide oversight and escalation support for Medical Monitors.
Contribute to the development and revision of Medical Monitoring SOPs.
Manage the assignment, transition, and training of Medical Advisors, Medical Monitors, and Study Physicians.
Collaborate with other departments to ensure quality service delivery to sponsors.
Provide regular project status reports and performance metrics to the VP of Global Medical Affairs.
Stay updated with scientific knowledge in relevant areas to maintain efficiency and high standards.
Support business development activities, including proposal reviews, budget approvals, and out-of-scope authorizations.
Oversee a team of Medical Monitors and Medical Directors, ensuring career development and training.
Participate in strategic planning and decision-making for client projects and global medical strategy.

Qualifications:

Medical Doctor degree (board certification and/or specialty preferred).
Extensive experience in clinical research and medical monitoring.
Strong global team management experience and leadership skills.
Expertise in clinical research, drug safety, and development processes.
Business development experience, including proposal review and bid defense participation.
Excellent communication, organizational, presentation, and documentation skills.
Ability to work independently and in multidisciplinary teams, managing tight deadlines and shifting priorities.
In-depth knowledge of GCP, ICH guidelines, and global drug safety regulations.
Strong strategic thinking and problem-solving abilities.
Proven leadership and mentoring skills, with the ability to develop and manage staff performance.
Willingness to engage in new business opportunities and expand Ergomed’s client base.

Additional Information:
At Ergomed, we value diversity, equity, and inclusion, creating a workplace where people from all backgrounds, genders, and cultures can thrive. We believe our people are our greatest asset and contribute directly to our success in improving patient lives.

We offer:

Training and career development opportunities.
A strong emphasis on personal and professional growth.
A friendly and supportive work environment.
Opportunities to collaborate with colleagues across the globe, using English as the company language.

Our core values drive everything we do, and if they resonate with you, we would love for you to join Ergomed and help us shape the future of medical affairs.

We look forward to your application.

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Medical Monitor (Oncology Experience)

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