To Discuss more about this job opportunity, please reach out to Deepak Arya (LinkedIn URL - www.linkedin.com/in/deepak-arya-8a79aa22a/), email your updated resume at Email - deepak.arya@collabera.com. Thank you!

Pay Range: $90 to $100 an hour (Negotiable based on the Experience)

Client Industry: Phamraceutical

Location: Florham Park, NJ or Remote
Duration: 12 Months Contract (Possibility of Extension based on business needs and performance.)

Job Summary:

• The Director Medical Monitor will provide medical oversight, clinical data review, and interpretation support for early phase and late phase clinical development programs.
• The role will focus on oncology studies and will support safety, tolerability, efficacy, and clinical data assessment throughout ongoing trials.
• This position will also lead structured training for scientific directors and medical directors on medical monitoring practices, clinical data review, and applicable review platforms.
• The individual will collaborate with clinical development, clinical operations, pharmacovigilance, data management, biostatistics, regulatory, and CRO teams.
• The role requires strong medical judgment, communication skills, clinical trial knowledge, and the ability to identify and escalate clinically significant findings.

Key Responsibilities:

• Lead training sessions for scientific directors and medical directors covering clinical data review and medical monitoring best practices.
• Deliver foundational and advanced training on EDC review, query generation and resolution, listings, patient profiles, aggregate data, and clinical review platforms.
• Review and interpret accumulating safety, tolerability, and efficacy data for assigned studies and programs.
• Provide medical monitoring oversight and identify, assess, document, and escalate important clinical and safety findings.
• Review serious adverse events and patient narratives for completeness, accuracy, medical relevance, and appropriate follow up.
• Identify data inconsistencies, emerging trends, and potential safety signals and communicate findings to study teams and stakeholders.
• Review data cleaning metrics and support resolution of clinical data issues.
• Review and interpret Tables, Listings, and Figures and support clinical data review activities.
• Support dose escalation review and clinical data interpretation in early phase oncology studies.
• Develop, oversee, or review CRF completion guidelines, medical review guidelines, and medical monitoring plans.
• Collaborate with clinical scientists, clinicians, biostatisticians, data management, pharmacovigilance, regulatory teams, and CRO partners.
• Support study team readiness for safety review meetings, internal data reviews, external data reviews, and dose escalation discussions.
• Develop training materials, job aids, and standardized guidance for medical monitors and scientific directors.
• Mentor team members on clinical data review practices, medical judgment, and interpretation of clinical trial data.
• Maintain awareness of protocol specific risks, stopping rules, escalation criteria, and monitoring plans.

Required Qualifications:

• Five to seven years of experience in clinical development, medical monitoring, clinical trials, or clinical data review.
• Hands on experience with medical monitoring activities and clinical trial data review.
• Strong experience with safety review, adverse event assessment, serious adverse event review, and clinical safety escalation.
• Experience reviewing patient profiles, listings, clinical data, and data cleaning metrics.
• Experience working with EDC systems and clinical trial data review processes.
• Experience collaborating with cross functional clinical development, data management, biostatistics, pharmacovigilance, regulatory, and CRO teams.
• Strong communication, clinical judgment, problem solving, and stakeholder management skills.

Preferred Qualifications:

• Advanced clinical, medical, or scientific degree.
• Experience supporting oncology clinical development programs.
• Experience with early phase oncology studies and dose escalation activities.
• Experience with Spotfire, J Review, safety dashboards, and related clinical review platforms.
• Experience reviewing Tables, Listings, and Figures.
• Experience developing or reviewing CRF completion guidelines, medical review guidelines, and medical monitoring plans.
• Demonstrated experience training or mentoring medical monitors, scientific directors, medical directors, or clinical development professionals.
• Experience with translational medicine or biomarker driven oncology studies.

Benefits: The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)