Do you want to be a part of a team that gives hope to patients with rare and life-threatening diseases? Do you thrive in an innovative, growth-oriented environment? At WEP Clinical, we are looking for an experienced Medical Monitor interested in joining us in an exciting phase of high growth and helping us shape the future of clinical research.
WEP Clinical is a market leader in Expanded Access Programs (EAP) & Post-Approval Named Patient Programs. We are a team of experts with over 15 years of experience, having distributed medicines in over 120 countries worldwide.
The Medical Monitor serves as the primary medical and scientific expert for clinical trial protocols and Expanded Access Programs (EAPs), playing a crucial role in ensuring the accuracy, integrity, and successful execution of studies. As the protocol expert, the Medical Monitor guides investigators and internal/external teams in implementing and adhering to the study protocol. This includes but is not limited to medical and safety monitoring, data interpretation/presentation, and providing expert input on all medical aspects of the trial. The Medical Monitor collaborates with clinical, regulatory, and operational teams to ensure trials meet the highest standards of ethical and scientific rigor.
What You'll Do:
* Act as the primary point of contact for all medical-related inquiries from investigators, regulatory agencies, and internal/external teams, providing clarification and ensuring consistent protocol interpretation.
* Monitor the clinical trial and/or Expanded Access Programs (EAP) to ensure participant's safety, data accuracy, and compliance with the protocol. Address medical issues as they arise throughout the study and/or program.
* Book and lead conference calls with investigators to discuss inclusion/exclusion criteria and provide personalized attention to ensure optimal site selection and patient recruitment.
* Serve as the primary medical expert for the clinical trial protocol, ensuring full comprehension and adherence by investigators, study teams, and stakeholders.
* Review adverse events (AEs), serious adverse events (SAEs), and other safety-related reports to ensure proper documentation and timely reporting.
* Provide causality assessment of adverse events (AEs), especially those that may request expedited reporting to regulatory authorities.
* Work with Data Safety Monitoring Boards (DSMBs) and other safety committees to provide safety oversight and evaluate ongoing trial data for participant safety.
* Provide ongoing training and support to investigators, site staff and internal/external teams on the protocol and therapeutic area, ensuring thorough understanding and adherence to the medical and scientific objectives of the study.
* Participate in investigator meetings, site initiation visits, and study-related training to present and explain protocol-related issues, clarify eligibility criteria, and address any medical concerns.
* Lead protocol, treatment guidelines and other project documents by providing critical medical input on study design, endpoints, inclusion/exclusion criteria, and overall trial/program methodology.
* Provide oversight to ensure that study conduct aligns with the protocol, identifying, classifying, and resolving any deviations, as well as ensuring the scientific and ethical integrity of the trial.
* Collaborate closely with clinical operations, regulatory, and project management teams to ensure trials comply with Good Clinical Practice (GCP) and regulatory requirements.
* Work with pharmacovigilance teams to ensure timely and accurate safety reporting and management of safety signals during the trial.
* Represent medical affairs in marketing and sales efforts by developing project bid proposals, participating in bid defence meetings, and performing client presentations, as requested.
* Provide expert medical guidance in cross-functional meetings, helping to resolve protocol-related challenges and ensuring the scientific objectives of the trial are met.
Qualifications
* Medical Doctor (MD) degree or PhD in health-related field required.
* At least 5+ years of relevant clinical research experience, preferably medical monitoring.
* Ability to travel internationally and domestically up to 25%
* Experience in EAP / CUP / NPP is preferred.
* Proven experience in protocol development, implementation, and interpretation.
* Experience in safety monitoring, adverse event reporting, and medical data review in the context of clinical trials.
* In-depth knowledge of clinical trial design, regulatory requirements, and drug development processes.
* Computer literacy and proficiency in Microsoft Office, particularly Excel, Word, and PowerPoint.
* Exceptional leadership, communication, and interpersonal skills to collaborate effectively with diverse teams and external stakeholders.
* Strong analytical and problem-solving abilities to make data-driven decisions and navigate complex challenges in the healthcare sector.
* Excellent interpersonal, communication, and organizational skills, as well as the ability to work independently and in a team environment, are required.
What We Offer:
We value our employees at WEP Clinical and believe they are our greatest asset. As a member of our team, you will be able to work on projects that make a meaningful difference in patients' lives. We are committed to fostering a supportive and collaborative work environment where employees are encouraged to share their ideas and work together to achieve our mission of delivering treatment to patients. Additionally, you will receive:
* Competitive salary and benefits package including comprehensive health insurance, discretionary annual bonuses, personal development allowance, pension schemes, summer hours, company socials and more!
* Opportunity to work in a small but dynamic team environment;
More About Us:
WEP Clinical is a specialist services company that partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over a decade of experience distributing products worldwide to treat unmet patient needs. Our services include: Expanded Access Programs (EAPs), Named Patient Programs (NPPs), Clinical Trial Supplies (Comparator & Ancillaries), Wren Nursing (Clinical Trial Home Nursing & Clinical Education) and Hospital Supply of Unlicensed Medicines.
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