Clinical Data Manager II

Pharmapace welcomes qualified and motivated candidates to apply for Clinical Data Manager II. Pharmapace is a fast growing and specialized consulting/outsourcing company serving the biotech and pharmaceutical companies in their clinical development programs. We offer a stimulating working environment and excellent career growth opportunity.

• Lead and oversee all data management activities for assigned studies, ensuring compliance with GCP, ICH, and company standards.
• Serve as the primary contact for sponsors, vendors, and sites on all data-related matters.
• Manage database setup, design, and validation, including CRF/eCRF design, annotation, database specifications, and validation testing.
• Oversee data integrity and quality through query management, data listings review, and discrepancy resolution.
• Perform data management closeout activities including SAE reconciliation, medical coding, and database quality control through database lock.
• Support and/or lead internal and sponsor meetings, providing clear updates and technical guidance on data management deliverables.
• Contribute to business development activities, including participation in client meetings and proposal discussions.
• Train and mentor junior data management staff, supporting their technical and professional growth.
• Ensure adherence to project timelines, deliverables, and budget constraints, escalating risks or issues proactively.
• Maintain proper study documentation and ensure compliance with trial master file requirements.
• Contribute to process improvement initiatives and share best practices across the department.

• Associate’s degree with a minimum of 4 years of data management lead experience, or equivalent 4–6 years of industry experience.
• BS/MS in Life Sciences or technical discipline with at least 3 years of data management lead experience preferred.
• Proven experience managing moderate to complex projects across both paper and EDC studies; global project experience preferred.
• Solid understanding of FDA, ICH, GCP, NDA, IND, and other regulatory guidelines.
• Strong knowledge of clinical data management principles and systems.
• Excellent oral and written communication skills with the ability to build rapport with sponsors, sites, and vendors.
• Strong analytical, organizational, and problem-solving skills with high attention to detail.
• Proven ability to lead data management tasks independently with minimal supervision.
• Proficiency in Microsoft Office Suite; familiarity with SAS or other programming tools a plus.
• Ability to manage multiple priorities, work effectively in a team environment, and mentor junior colleagues.
• Professional demeanor, proactive mindset, and commitment to quality and accuracy.

Pharmapace offers competitive salaries plus stock options, 401K plan with company match, health/dental/vision insurances, and holiday/vacation benefits. Pharmapace is an equal opportunity employer. We prohibit unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin/ancestry, age, disability, marital status, and veteran status.