Associate Director Clinical Operations

Join to apply for the
Associate Director Clinical Operations
role at
Grifols
.
Location: Grange Castle International Business Park, Grange, Co.
Dublin, D22 K2R3
Overview
Oversees the clinical feasibility assessment and strategic planning of clinical trial programs or studies.
Executes global programs in one or more assigned therapeutic areas from decision to start of a clinical development up to market authorization.
Manages budgets, timelines, and quality of deliverables in accordance with ICH-GCP, regulatory requirements, SOPs and study protocols.
Responsibilities
Oversees integrity of clinical data to ensure data meet GCP standards.
Maintains knowledge of the literature for the indication being studied; reviews and summarizes published literature for the therapeutic area of interest.
Participates in cross-functional project teams and presents program information to internal and external audiences.
Provides clinical review/input to Investigator Sponsored Research proposals.
Assesses best strategic path forward for a clinical program and drives clinical strategy recommendations including timelines and costs to key stakeholders.
Orchestrates expert meetings to elucidate the best clinical path forward for a clinical program.
Identifies risks, mitigations, opportunities and contingency plans for assigned programs/studies; escalates significant issues to senior management in a timely manner.
Drafts clinical components from decision to start of a clinical development up to market authorization gates and liaises cross-functionally to provide clinical input on development stages and Target Product Profile as necessary.
Provides clinical status updates to the Project Management Office (PMO) and to Upper Management.
Manages direct reports through performance evaluations and addresses professional development; ensures compliance with trial-specific training requirements.
Manages vendor timelines, budgets, and resources against the approved clinical development plan; participates in vendor specifications and vendor selection; oversees third-party vendors including CROs and central labs; reviews monitor reports and protocol deviations; oversees TMF status; supports corrective actions.
Provides guidance to resolve escalated study conduct issues and responds to questions from study center personnel, regulatory authorities and ethics committees.
Provides clinical review/input to clinical documents (protocols, investigator brochures, periodic safety reports, clinical study reports) and ensures data integrity prior to regulatory submissions.
Drafts or reviews publications from clinical study data and literature reviews; participates in regulatory authority meetings.
Partners with Biometry to develop case report forms, data management plans and statistical management plans; reviews data deviations and data listings for data integrity.
Oversees QA/Audit responses and contributes to process improvements; prepares for and supports site inspections and internal inspections; manages corrective and preventive actions to quality deviations.
Leads team training and participation in internal and external trainings (e.g., kick-off meetings, Investigator's meetings).
Qualifications
10+ years of experience in clinical research, including 2–5 years in a study management/leadership role; advanced verbal, written and interpersonal skills for cross-functional issue resolution.
Advanced strategic thinking for proactive planning and decisive decision making.
Strong ability to set and meet deadlines, multitask, and prioritize by program/study needs.
Ability to facilitate and/or present at departmental, study, project and investigator meetings.
Leadership and clinical trial/project management experience in managing study teams, vendors, and cross-functional personnel.
Bachelor's degree in a relevant discipline; typically 10 years of clinical research experience with at least 6 years in trials management/leadership, including clinical document production, trial execution, feasibility and strategy.
Master's degree or higher in a relevant discipline (2 years' experience equivalence for a MD and 4 years for a master's degree).
We understand that self-doubt can hold talented individuals back from applying for opportunities.
We encourage everyone who meets the qualifications to apply – we're excited to hear from you.
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