Senior Clinical Trial Manager
BioSpace is partnering with a clinical-stage biotechnology company developing first-in-class immunology therapeutic product candidates to patients.
This position is accountable for all operational activities related to planning, executing/conducting and reporting out of assigned clinical studies in support of the organization's product development portfolio. The Sr. CSM will independently organize and manage multiple activities related to clinical studies, while simultaneously ensuring study milestones are met and studies are completed in accordance with the protocol and ICH/GCP requirements. Duties involve contributions to multiple clinical studies of differing phases, project planning, budgeting, participating in the selection of clinical sites, selection and management of clinical vendors, organizing and conducting Investigator Meetings, making clinical presentations, etc. The successful candidate drives the conduct of the study, maintains study level reporting systems, progress reports and trackers to ensure all study operational aspects are on track in support of the organization's clinical programs.
- Effectively manage multiple complex studies and/or programs simultaneously to ensure time, quality, and cost metrics are adequately defined and met. Identify and manage potential risks and impacts with regard to:
- Site identification/qualification
- Site start-up and initiation (e.g., CTAs, Study budgets, Enrollment/Retention Plans, Monitoring Plans)
- Study conduct
- Data collection, management, and analysis
- Final data/reporting
- Effectively collaborate with the operational project team members and stakeholders from CMC, Finance, Legal and Regulatory Affairs as necessary regarding performance (KPIs) related to clinical study vendor(s) ensuring compliance with study specifications (i.e., timelines, deliverables, budgets) and applicable SOPs
- Execute study management with thorough understanding of the drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMEA) and applies this knowledge to all aspects of the study (startup through conduct to closeout)
- Participate in study center selection, pre-study qualification, initiation, and closeout.
- Coordinates and conducts study monitoring with CRAs to ensure study compliance, data quality, proper documentation and study completion
- Oversees plans and preparation for/of Essential Documents (e.g., Patient Informed Consent Forms, 1572s,)
- Identify, manage and supervise clinical CRO and consultant activities.
- Negotiate clinical trial agreements and budgets; manage the budget and vendor site payments.
- Participate in developing study-related documents such as protocols, SOPs, work instruction documents, informed consent forms, and case report forms (CRFs), etc.
- Participate in the preparation and writing of Investigator’s Brochures and clinical sections of regulatory documents such INDs, DSURs, NDAs, etc. (and/or international equivalents).
- Participate and support publications based on the clinical program.
- Communicate with cross-functional colleagues (Regulatory, QA, CMC, Finance, etc.) to ensure all stakeholders are informed of and aligned with clinical activities.
- Recommend and implement innovative process ideas that impact clinical trials management and cost efficiency.
Education & Experience
- BA/B S in related scientific or healthcare field and
- 8 years of clinical operations experience gained working in a pharmaceutical/biotechnology industry environment, with a strong preference for immunology, allergy, dermatology and/or biologics experience;
- CCRA preferred.
Knowledge and Competencies
- Working knowledge of cross-functional clinical processes including data management, biostatistics, medical writing, drug safety/pharmacovigilance, and regulatory affairs
- Proven ability to plan, conduct and manage clinical operations from early through late phase trials, with global trial experience is preferred.
- Demonstrated ability to manage CROs, central laboratories, and other clinical study vendors.
- Ability to contribute to the development of clinical protocols, project-related documents, clinical study reports and summary documents for regulatory submissions.
- Demonstrated ability to handle a high volume of highly complex tasks within a given timeline
- Demonstrated, effective planning and project management skills, including risk assessment, contingency planning and ability to prioritize.
- Effective communication and interpersonal skills, with the ability to successfully articulate plans, results and analysis to project teams and senior management to build commitment and alignment; listens and seeks clarification; responds effectively to inquiries or complaints.
- Ability to build strong relationships with external parties, such as key opinion leaders and clinical investigators.
- Excellent organizational and problem-solving skills with the capacity to organize assignments and work within deadlines