Volt Workforce Solutions Sr. Clinical Study Manager in San Diego, California
Sr. Clinical Study Manager in San Diego, CA at Volt
Date Posted: 3/25/2020
Employee Type: Contingent
Location: San Diego, CA
Job Type: Scientific/Biotech
Duration: 0 weeks
Date Posted: 3/25/2020
Job ID: 224470
Contact Name Volt Branch
Volt has partnered with a a clinical-stage biotechnology company developing first-in-class immunology therapeutic product candidates to patients, who is now hiring for a Sr. Clinical Study Manager!
This is a direct hire opportunity, with competitive salary and benefits, located in San Diego!
Focusing on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, we develop our product candidates using our proprietary antibody discovery technology platform, which is based upon a breakthrough understanding of the natural process of antibody generation, known as somatic hypermutation, or SHM. This replicates th natural process of antibody generation in vitro . Our strategy is to advance the development of our proprietary product candidates, and where applicable, establish partnerships with leading biopharmaceutical companies where we retain certain development and commercialization rights.
This position is accountable for all operational activities related to planning, executing/conducting and reporting out of assigned clinical studies in support of AnaptysBio 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 AnaptysBio 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 start-up and initiation (e.g., CTAs, Study budgets, Enrollment/Retention Plans, Monitoring Plans)
Data collection, management, and analysis
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;
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
Volt is an equal opportunity employer
In order to promote this harmony in the workplace and to obey the laws related to employment, Volt maintains a strong commitment to equal employment opportunity without unlawful regard to race, color, national origin, citizenship status, ancestry, religion (including religious dress and grooming practices), creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), sexual orientation, gender identity, gender expression, marital or parental status, age, mental or physical disability, medical condition, genetic information, military or veteran status or any other category protected by applicable law.