Clinical Study Manager – 15‑Month Contract
Grifols, a global healthcare company, invites applications for a Clinical Study Manager to cover a maternity role for 15 months. The position supports clinical trials and studies in one or more therapeutic areas, ensuring compliance with ICH GCP, regulatory requirements, SOPs, and study protocols under Program Leader supervision.
Key Responsibilities
* Oversee the integrity of clinical data to meet GCP standards, under Program Leader supervision.
* Prepare clinical status updates for the Project Management Office (PMO) and upper management.
* Assist Program Leader in assessing strategic paths for clinical trials and contribute to strategy recommendations.
* Manage direct reports, conduct performance evaluations, and address professional development.
* Lead and participate in internal and external training activities for clinical trials, including kick-off and investigator meetings.
* Ensure appropriate training for CRO staff, vendors, investigators, and study site personnel.
* Contribute to the RFP process, vendor selection, and oversee third‑party vendor performance, including CROs and central laboratories.
* Conduct sponsor site visits, document findings, and follow up on corrective and preventive actions.
* Lead meetings with CROs, vendors, and cross‑functional teams to ensure quality, budget, and timelines.
* Review site and vendor invoices to ensure project expenses align with work performed.
* Oversee in‑house and vendor monitoring activities, identify protocol deviations, and implement corrective and preventive actions (CAPAs).
* Draft, review, and approve key documents such as informed consent, site worksheets, pharmacy manuals, laboratory manuals, and monitoring plans.
* Ensure timely execution of clinical studies and collaboration with biometry for data transfers and analyses.
* Maintain awareness of serious adverse events (SAEs) and ensure appropriate SAE/SUSAR reporting to IRB/IEC and investigators.
* Assist in managing the Trial Master File (TMF) process, ensuring accurate filing and QC plan administration.
* Contribute to responses and preparation for vendor/site audits, internal inspections, and site inspections.
* Supervise the quality of clinical trials and implement CAPAs for quality deviations and misconduct.
* Support the clinical supply chain by managing certificates, coordinating manufacturing, packaging, labeling, and shipping of supplies.
Qualifications
* Advanced verbal, written, and interpersonal communication skills for cross‑functional issue resolution.
* Advanced strategic thinking for proactive planning and decisive decision making.
* Advanced ability to set and meet deadlines, multitask, and prioritize program or study needs.
* Advanced facilitation and presentation skills for study and investigator meetings; ability to train and mentor CRAs.
* Typically requires 7–8 years of clinical research experience, including 3 years in a study management or leadership role.
* Strong leadership and clinical trial/project management experience managing study teams, vendors, and cross‑functional personnel.
* Bachelor's degree in a relevant discipline.
Desirable
* 8 or more years of clinical research experience, including 3–5 years in a study management or leadership role.
What We Offer
* Highly competitive salary
* Group pension scheme – contribution rates up to 7%
* Private medical insurance for the employee
* Ongoing career development opportunities in a rapidly expanding environment
* Succession planning and internal promotions
* Education allowance
* Wellness activities, including social events (e.g., golf, padel, summer events)
Location
EMEA: Ireland – Dublin (Grange Castle, Dublin)
Employment Type
Contract (15 months)
Seniority Level
Mid‑Senior level
We encourage everyone who meets the qualifications to apply – we’re excited to hear from you.
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