Medical Monitor / Director

job summary:

As the world's largest staffing and recruitment agency, we are dedicated to helping you find the ideal role that offers growth and development opportunities within the life sciences sector. By working with a recruiter, you gain access to a vast network of leading employers and detailed insights into a wide range of positions. One of our premier partnerships is with a research-driven biopharmaceutical powerhouse focused on developing treatments for complex, hard-to-cure diseases. This esteemed company has brought 32 groundbreaking products to market, including Humira and Lupron, making a significant global impact. If you're ready to make your mark in the field and contribute to the future of innovative therapies, this is the opportunity for you!

location: Telecommute
job type: Contract
salary: $150.00 - 180.27 per hour
work hours: 9 to 5
education: Doctorate


responsibilities:

• Under appropriate supervision, manages the design, implementation, and evaluation of clinical study protocols in support of the clinical development program and aligned with the overall Product Development Plan, applying sound medical and scientific judgment, knowledge of compliance and regulatory requirements, and awareness of Company's customers, markets, business operations, and emerging issues.
• Provides oversight of clinical studies, including monitoring overall study integrity and reviewing, interpreting, and communicating accumulating safety and efficacy data for the study. In collaboration with Company Clinical Operations, oversees study enrollment, timelines, and key deliverables, and is responsible for assessing and reporting serious adverse events in accordance with corporate policy and applicable regulations for assigned protocols.
• Oversees project-related education and training for investigators, study site personnel, Company study staff, and clinic staff, as appropriate.
• Maintains current expertise in the therapeutic area through medical literature and other learning opportunities, as well as through familiarity with relevant technologies and professional developments.
• Ensures compliance with Good Clinical Practice, pharmacovigilance standards, SOPs, and all other applicable quality and safety standards in the conduct of research and patient care.
• Demonstrates the highest standards of medical ethics at all times and seeks appropriate consultation when patient care issues or protocol-related questions are outside the scope of practice or expertise.
• Collaborates effectively with cross-functional partners across Clinical Development, Clinical Operations, Medical Affairs, Regulatory Affairs, Safety, Quality Assurance, and other matrix teams.
• Communicates scientific, clinical, and operational findings clearly and effectively to internal and external stakeholders.
• Participates in quality assurance and continuous quality improvement activities, including clinical audits, peer review, and regularly scheduled review meetings, as applicable.
• Advises/updates the Executive Director of clinical and operational matters.
• Contributes to training and knowledge sharing within the Clinical Development team, including procedures, clinical monitoring practices, data quality, actionable data interpretation, and workflow integration, as appropriate.
• Attends staff, committee, board, or other meetings as required to represent the department, clinic, or organization.

qualifications:

• Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-U.S. equivalent degree, with relevant therapeutic specialty experience in an academic or hospital setting. U.S. residency training is strongly preferred; completion of a subspecialty fellowship is desirable. 5+ years of experience
• Lymphoma clinical experience and/or experience with lymphoma trials is preferred.
• Medical monitoring experience, preferably with immunotherapies, is highly desirable.
• Proven ability to collaborate in a cross-functional environment.
• Clinical trial experience in the pharmaceutical industry, academia, or an equivalent setting is preferred.
• Knowledge of clinical trial methodology, including medical monitoring, study oversight, and regulatory and compliance requirements governing clinical trials, is desirable.
• Ability to work effectively with global sites across multiple time zones.
• Demonstrated ability to independently interpret emerging safety and efficacy data, proactively identify risks, ensure accurate data entry, and appropriately escalate issues.
• Ability to interact effectively with both internal and external stakeholders to support global scientific and business strategy.
• Excellent oral and written communication skills in English.
• Strong organizational skills and attention to detail.
• Demonstrated ability to manage multiple priorities in a fast-paced, matrixed environment.
• Familiarity with Good Clinical Practice, pharmacovigilance principles, and clinical research compliance requirements.

skills: Good Clinical Practice (GCP)


Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].


Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).


This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.