Medical Monitor

Job#: 2004009

Job Description:

Medical Monitor 2004009
Location: Cambridge, MA (Hybrid)
Science: Biologics
Therapeutic Area: Rare Disease
Job Overview: This person will be responsible for patient safety and providing medical guidance during the execution and reporting of clinical trials, overseeing global clinical studies and serving as the point of accountability for an ongoing Ph. 3 program and other clinical programs to ensure patient safety.
Responsibilities:

• Manage assigned clinical trials as the Medical Monitor, providing oversight and medical expertise throughout the trial, including protocol development, patient screening, enrollment, and safety monitoring, and answering medical questions from sites or project team.
• Review and assess adverse events (AEs, SAEs) and other safety data, making recommendations for risk mitigation and safety protocol adjustments as necessary.
• Analyze clinical trial data, patient information, and lab results to ensure compliance with medical and safety standards throughout the study, while collaborating closely with cross-functional teams in clinical operations, regulatory affairs, and data management to drive trial execution.

• Conduct medical monitoring tasks, including medical data review, medical listing review, eligibility review, protocol review, CSR review, and regulatory communication, with experience in metabolic diseases or related conditions being a plus.
• Possess at least 3 years of pre-launch clinical trial experience as a medical monitor in pharmaceutical or biotechnology companies, preferably with prior exposure to rare diseases and PKU.
• Demonstrate familiarity with clinical medicine, clinical trial operations, GCPs, regulatory requirements, and ethical standards, along with strong knowledge of the clinical research process and in-depth understanding of Good Clinical Practices.

About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT™
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.
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EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178.