Pharmapace welcomes qualified and motivated candidates to apply for Clinical Data Manager I. 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.
Key Responsibilities
- Lead data management activities for assigned clinical trials, including data collection, entry, query management, and database updates
- Serve as the primary contact for sites, sponsors, and vendors regarding data management issues.
- Support study startup activities including CRF/eCRF design, CRF annotation, database specifications, validation specifications, and testing.
- Perform quality control checks, reconcile SAE data, and ensure accuracy of medical coding and final database outputs.
- Participate in internal and sponsor meetings, providing data-related updates, training, and technical guidance.
- Mentor and train junior staff on project-specific tasks and general data management processes.
- Manage project resources within budget and timelines, escalating out-of-scope requests or potential issues to project management.
- Ensure study documentation is complete, accurate, and properly stored in trial master files.
- Apply prior project experience to proactively identify and resolve data management issues.
- Contribute to departmental goals and continuous improvement initiatives.
Qualifications:
Education & Experience:
- Associate’s degree with 3+ years of data management experience as a lead, or equivalent industry experience.
- BS/MS in Life Sciences or related technical field with 2+ years of data management experience preferred.
- Experience with study startup, maintenance, and closeout activities for both paper and EDC studies.
- Familiarity with FDA guidelines, ICH, GCP, NDA, IND, and other applicable regulations.
Skills & Competencies:
- Excellent verbal and written communication skills; ability to build rapport with sponsors, sites, and vendors.
- Strong interpersonal skills and professional demeanor.
- Ability to manage multiple projects simultaneously while adhering to deadlines and budgets.
- Attention to detail and strong organizational skills.
- Ability to mentor and guide junior staff.
- Technical skills: Intermediate Microsoft Office Suite; familiarity with SAS or other programming tools is a plus.
- Ability to work independently and as part of a team, including occasional remote work.
- Willingness to travel domestically or internationally (approximately 5%).
- Valid driver’s license and ability to rent a car as needed.
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.