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Grifols · 3 days ago

Associate Director of Clinical Operations

North Carolina, United States

Full-time

Onsite

Senior Level, Lead/Staff

5+ years exp

Grifols is a global healthcare company dedicated to improving health and well-being since 1909. The Associate Director of Clinical Operations will lead clinical studies, managing feasibility assessments, strategic planning, and operations for clinical trial programs in assigned therapeutic areas.

BiotechnologyHealth CareManufacturing

Responsibilities

Provides clinical input/review to clinical development program plans (e.g., strategies, budgets, timelines)

Provides clinical input/review to clinical documents and ensures the integrity of clinical data prior to submission to regulatory authorities (e.g., protocols, investigator brochures, clinical study reports)

Manages clinical timelines, budgets, and resources against the approved CDP in collaboration with PMO

Provides oversight to third party vendors (e.g., contract research organizations (CROs), central labs) and trains them on SOPs, as necessary. Manages vendor performance, including on time study completion, budget adherence, and quality deliverables along with the senior management

Participates in development of vendor specifications to ensure accurate interpretation of the protocol requirements (e.g. processes and data collection)

Provides collaboration with Biometry to ensure timely data transfers for data cleaning, review and analysis

Collaborates with Clinical Supplies to ensure timely manufacturing, packaging, labeling, shipping of clinical trial supplies for which the incumbent is responsible

Manages responses to audits, as necessary

Develops program/study status presentation materials during internal management and advisory meetings

Maintain awareness of SAEs that are reported

Identifies risks, mitigations, opportunities and contingency plans for assigned program(s) and study(ies)

Escalates significant issues on program(s) and study(ies) to senior management in a timely manner

Attends cross functional project team meetings

Maintains good knowledge of the literature for the indication being studied and reviews and summarizes relevant literature for the therapeutic area of interest, as necessary

Assesses feasibility and best strategic path forward for a clinical program and endpoints

Drives clinical strategy recommendations including timelines and cost to key stakeholders

Participates and contributes to internal and external training for clinical program (e.g. Kick-off meeting, Investigator meeting)

Qualification

Clinical trial managementRegulatory requirementsProject managementClinical practicesLeadership skillsIssue resolutionVerbal communicationWritten communicationInterpersonal skillsDecision-making

Required

Bachelor's degree in life sciences or Master's degree in biomedical science

Typically requires a minimum of 5 years of clinical research experience. (If Master's degree in biomedical science, equivalency is 3 years of pharmaceutical industry experience in clinical research)

Project or technical leadership experience required

Good knowledge of good clinical practices (GCPs), code of federal regulations (CFRs), ICH, and clinical trial management including monitoring and study management processes, regulatory requirements, drug safety requirements, data management and statistical processes, budgets, and financial tracking

Good project management skills, including effective planning and organizational skills

Good leadership skills in supervising direct reports and defining strategies for efficient program/study execution

Good verbal, written and interpersonal skills as well as motivational, decision-making and issue resolution skills

Good ability to recognize cultural and regional differences that affect medical standards and patient care

Good ability to manage multiple programs/studies

Good ability to prioritize and effectively manage changing priorities