Clinical Study Manager
Company: AnaptysBio, Inc.
Location: San Diego
Posted on: March 28, 2020
Position SummaryThis position is accountable for all operational
activities related to planning, executing/conducting and reporting
out of assigned clinical study in support of AnaptysBio product
development portfolio. The 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 AnaptysBio clinical
- Effectively manage multiple 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
- 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
- Oversees plans and preparation for/of Essential Documents
(e.g., Patient Informed Consent Forms, 1572s,)
- Identify, manage and supervise clinical CRO and consultant
- 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
- 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. Knowledge and
- 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
- 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
- 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 Physical
DemandsThe physical demands described here are representative of
those that must be met by an employee to successfully perform the
essential functions of this job. Reasonable accommodations may be
made to enable individuals with disabilities to perform the
essential functions.While performing the duties of this job, the
employee is regularly required to sit and talk or hear. The
employee frequently is required to use hands to finger, handle, or
feel. The employee is occasionally required to stand, walk, and
reach with hands and arms. The employee must occasionally lift
and/or move up to 10 pounds. Specific vision abilities required by
this job include close vision and ability to adjust focus in order
to read.Work EnvironmentThe work environment characteristics are
representative of those an employee encounters while performing the
essential functions of this job, typically in an open office
environment. Reasonable accommodations may be made to enable
individuals with disabilities to perform the essential functions.
- The noise level in the work environment is usually
- May be required to travel by plane or car 25-50% domestic
and/or international travel. RequirementsEducation & Experience
- BA/B S in related scientific or healthcare field and six years
of clinical operations experience gained working in a
pharmaceutical/biotechnology industry environment, with a strong
preference for immunology, allergy, dermatology and/or biologics
- CCRA preferred.
Keywords: AnaptysBio, Inc., San Diego , Clinical Study Manager, Healthcare , San Diego, California
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