Associate Director Clinical Operations (Remote)
Posted on: January 16, 2022
Position OverviewThis position is accountable for all
operational activities related to planning, executing/conducting
and reporting out of assigned clinical studies in support of
product development portfolio. The AD Clin Ops 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
clinical programs.----This position reports to the Sr. Director,
Clinical Operations--Primary Responsibilities:
- 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
- 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.
- Bachelor's degree in a scientific or healthcare field
- 8 years of clinical operations experience gained working in a
pharmaceutical/biotechnology industry environment, with a
preference for immunology and antibody/biologics experience; CCRA
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
- 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
Keywords: BioPhase, Baltimore , Associate Director Clinical Operations (Remote), Executive , Baltimore, Maryland
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