Sr. Manager, Clinical Data Management - Contract - San Diego
Proclinical is seeking a Sr. Manager, Clinical Data Management to support data management activities in phase 1 - 4 clinical trials.
Primary Responsibilities:
The successful candidate will oversee outsourced studies, ensuring the accurate interpretation and translation of study protocols into validated data collection applications, tools, and systems. Your role will involve data cleaning, validation, and delivery of data for analysis. Strong knowledge of regulatory guidelines, project management principles, risk assessment, and problem-solving skills are essential. Effective communication, both written and verbal, is critical for managing expectations and delivery across cross-functional study teams, CROs, leadership, and management.
Skills & Requirements:
- Bachelor's degree or equivalent combination of education.
- 6+ years of relevant experience in clinical data management within biotech or pharmaceutical/drug development.
- Preferred experience in vendor management and global operations.
- Ability to work effectively in a smaller company environment, particularly in early development roles.
- Strong planning and project management skills, including risk assessment and contingency planning.
- Effective communication and interpersonal skills.
- Ability to work as a team player in a complex, changing environment.
- Self-motivated, independent, and results-oriented.
- Excellent organizational and problem-solving skills with attention to detail.
The Sr. Manager, Clinical Data Management's responsibilities will be:
- Manage all data management activities according to quality standards and regulatory requirements, ensuring adherence to project timelines and budget.
- Oversee the development of CRFs and CCGs with other functional area representatives, ensuring all data management databases are developed and validated.
- Manage interactions and deliverables with third-party vendors and CROs, ensuring proper execution of data management activities and providing relevant metrics to the study team.
- Oversee data review, reconciliation, and cleaning activities for all assigned studies.
- Ensure high data quality by adhering to corporate, industry, and regulatory standards.
- Monitor outsourced data management activities for efficiency and regulatory compliance, providing feedback on vendor selection.
- Cultivate effective working relationships with colleagues, junior staff, vendors, and management, solving problems and escalating issues with proposed solutions as needed.
- Educate clinical team members on data management processes, workflow, and data standards.
- Review and provide input on protocols, SOPs, and work instructions for the data management department.
- Perform ongoing review of study documentation in the trial master file to ensure audit readiness.
- Perform other related duties as required and assigned.
If you are having difficulty in applying or if you have any questions, please contact Bodin Forsen at B.Forsen@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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