Job Description

Position: Clinical Data Manager

FLSA Status: Exempt

Location: Hybrid/Remote

Salary: $250,000-$300,000

Are you ready to embark on an exhilarating journey with a team that's passionate about making a difference? Pharmaron is thrilled to invite you to join us as our newest Medical Monitoring Director If you're craving a role that offers challenges, growth, and meaningful impact, then this is the opportunity you've been waiting for.

Job Overview:

We are looking for a Director of Medical Monitoring to lead the medical oversight of the clinical studies and ensure subject safety, site medical compliance with protocol and ICH-GCP requirements, and overall scientific integrity and quality of the clinical studies in the US

Roles and responsibilities

Proactively provide the medical leadership and scientific input to improve the project quality in the function of medical science, pharmacovigilance, clinical operation, and data management etc.

Medical Science and Clinical Operation

• Clinical and scientific expertise to the clinical trial protocol development process, medical support from IND to NDA strategy for our client product
• MMP/SMP development
• Medical support for monitoring guidelines, statistical analysis plans, informed consent documents, clinical review forms, data edit checks, medical data review planning.
• Provide medical review for AE coding, lab data, medical history, concomitant medications etc.
• Medical assessment of subject eligibility
• Support clinical operation team in medical query, emergency etc.
• Review of protocol deviations & conduction consistency in medical compliance of the protocol
• Medical training of TA, protocol, and other medical relative topics etc.
• Participate SRC and IDMC activities.
• Medical support for regulatory activities such as IND and NDA/BLA submission, regulatory discussion etc.

Pharmacovigilance and Data Management

• Responsible for medical review of serious adverse events and non-serious adverse event in support of drug safety activities for clients.
• Medical review of assigned cases to include review of narrative, coding (e.g. MedDRA) and accurate assessment of Adverse Events (serious and non-serious) and of Adverse Drug Reactions (serious and non-serious).
• Perform weekly review of non-serious line listings for potential upgrades to serious and provide medical guidance to triage staff.
• Write medical query and similar event analysis and provide causality assessment for individual case.
• Review of aggregated reports (e.g. patient profiles, line listings, IND Annual Safety Reports, DSUR and RMP) in terms of product safety profile.
• Provide assessment of safety issues arising in clinical trials and escalate those to the line manager within the organization or/and client.
• Review and use of Clinical Trial Protocols, Product Information, Company Core Data Sheet and any other product related information needed in the course of assigned project.
• Review and provide input to the Project Specific Procedures and participate in project related meetings.
• Communicate with the client to an extent as described in the Project Specific Procedures.
• Provide assistance in the preparation and conduct of coding convention.
• Potentially, provide support to the site support (call), including provision of the Product related information to the callers as well as review and assessment of reported adverse reactions.
• Involve in the SAE reconciliation between the clinical database and the safety database
• Lead the IDMC review and signal detection analysis.

Management Responsibilities:

• Lead department to identify Medical Monitor/ Medical safety assessment process needs and areas for improvement.
• Lead in the development of department or cross functional SOPs, policies and working guidelines.
• Manager employee associated with MM/Safety Physician, assign and coordinate projects within the department.
• Be responsible for the internal training courses related to MM/Safety Physician. Provide on-job training to MM/Safety Phycision.
• Participate in and support business development activities.

Requirements

• Medical degree
• More than 10-15 years of industry experience in pharmaceutical companies or CRO companies, and more than 5 years of management leadership positions.
• Proficient in clinical research and protocol design, preferably with previous experience in implementing Phase I-III clinical trials.
• Familiar with relevant regulatory requirements such as Good Clinical Practice (GCP), drug supervision and management.
• Have the ability of strategic thinking, planning and practical operation; demonstrate the ability to predict, organize, plan and respond to changes and adjust the priority of project processing.
• Analyze complex situations and proactively identify key points to provide effective solutions for cross-departmental projects.
• Fluent in written and spoken English.

Why Pharmaron?

Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 21,000 employees and operations in the U.S., the U.K. and China. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.

Collaborative Culture: You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators.

Benefits: As part of our commitment to your well-being, we offer a comprehensive benefits package:

• Insurance including Medical, Dental & Vision with significant employer contributions
• Employer-funded Health Reimbursement Account
• Healthcare & Dependent Care Flexible Spending Accounts
• 100% Employer-paid Employee Life and AD&D Insurance, Short and Long Term Disability Insurance
• 401k plan with generous employer match
• Access to an Employee Assistance Program

How to Apply:

Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today!

As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.

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