Job Description

Job Description

Job Description

Position: Clinical Data Manager

FLSA Status: Exempt

Location: Hybrid/Remote

Salary: $60,000 - $80,000

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 Clinical Data Manager at our Somerset New Jersey facility! 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:

The Clinical Data Manager ensures the integrity, accuracy, and compliance of clinical trial data, adhering to regulatory requirements, SOPs, and data standards. Responsibilities include overseeing data quality, managing external data transfers, and ensuring database development follows CDISC or relevant standards. They lead study management activities, allocate resources, create timelines, and oversee data management tasks. Additionally, they participate in audits, communicate with stakeholders, assess risks, mentor junior staff, and lead project teams to ensure high-quality data management services aligned with client expectations.

Responsibilities:

• Responsible for ensuring the integrity, reliability, and accuracy of clinical trial data.
• Ensure that clinical data quality and consistency conform to applicable regulatory requirements, SOP(s), processes, and data standards.
• Ensure that external data conforms to standards outlined in the data transfer specification.
• Ensure all data management activities are compliant with GCP, relevant regulatory requirements, and SOP(s) of Pharmaron Clinical and/or Sponsor.
• Ensure that data/database programming and development follow and apply CDISC or applicable standards throughout the duration of a clinical trial.
• Acknowledge, follow, and be consistent with all Pharmaron Clinical policies and procedures.
• Act as the Lead Data Manager for clinical trials, arrange for resources and assess their workload.  Identify the work scope of the study and create a study timeline based on the clinical protocol.
• Participate in internal/external functional meetings.
• Oversight of all data management tasks related to a clinical trial as mandated by the scope of work.
• Monitor the project and ensure trial deliverables meet expected timelines and quality standards.
• Participate in internal/external audits and regulatory inspections.
• Communicate effectively and appropriately with internal & external teams, including vendors and clients.
• Provide risk management assessments for data management deliverables.
• Mentor and train other team members.
• Can perform all data management functions and responsibilities assigned to junior staff members.
• Lead clinical data management project teams in the delivery of services to clients to ensure the provided service is consistent with client needs, expectations, and contractual obligations.
• Build teamwork and improve processes and productivity by working within and across functional areas.
• Perform other duties as required.

What We're Looking For:

• Bachelor's Degree or above in clinical/pharmacy, science and technology, or related discipline preferred.
• At least 3 years' experience within a data management role, understanding of processes including study management, vendor management, CRF design, database set-up, edit check specification, DMPs, and data cleaning activities up to and including database lock.
• Demonstrated knowledge of GCP and other regulatory requirements for clinical trials.
• Demonstrated knowledge of the functions and activities of clinical trials.
• Good written and oral English communication, including working knowledge of medical terms.
• Knowledge of Microsoft Windows environment and its applications (Word, Excel, PowerPoint, Project, etc.)
• Strong ability to analyze issues and learn new things.
• High degree of enthusiasm and a strong sense of responsibility.
• Detail oriented, organized, and conscientious

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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