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Clinical Study Manager

Employer
Grifols
Location
Dublin West, Dublin
Salary
Negotiable
Closing date
21 Jun 2023

View more

Sector
Scientific
Job Type
Permanent
Hours
Full-time

Job Details

 

Clinical Study Manager

Provides guidance and oversight to internal and external project team members for the successful management of clinical operation activities in accordance with International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines, applicable regulatory requirements, company standard operating procedures (SOPs), and study protocols, along with the Program Leader's supervision.

 

What your responsibilities will be

  • Contributes to the oversight of integrity of clinical data obtained from ongoing and completed clinical trials to ensure data meets GCP standards, along with the Program Leader's supervision.
  • Project Management Office (PMO)/pCTSR:
  • Provides support in the preparation of clinical status updates to the Project Management Office (PMO) and to Upper Management.
  • Participates and contributes to internal and external training for clinical trials (e.g. kick-off meeting, Investigator meetings
  • Ensures appropriate training is conducted for clinical research organization (CRO) staff, vendors, investigators, and study site staff on study requirements and internal SOPs (if applicable)
  • Assist in the identification of study team protocol-specific training requirements and creates a trial-specific training plan for the study team.
  • Contributes to the Request for Proposal (RFP) process and participates in vendor selection.
  • Oversees third party vendors performance (e.g., CROs, central laboratories) including on time study completion, budget adherence, and quality deliverables along with senior management. In particular, may include the review of monitoring reports, approval of clinical plans, regular review of protocol deviations and oversight of the Trial Master File (TMF) status.
  • Assists in evaluation of vendor performance to ensure early mitigation/resolution of potential issues and serves in key role to develop/implement corrective action plans as appropriate.
  • Performs Sponsor Site Visits at selected sites to oversee the site and the monitoring performances, to increase the communication with the site and awareness of protocol burdens. Documentation of the Sponsor Visits and follow-up of appropriate corrective and preventive actions
  • Leads meetings with CROs, vendors, and multi-functional teams on a day-to-day basis to ensure quality, on budget and timeliness of deliverables.
  • Reviews site and vendor invoices to ensure that project expenses are in accordance with work conducted.
  • Reviews escalated issues from study clinical research associates (CRAs) to ensure adequate mitigation plans are implemented (e.g., investigational site monitoring and site audit report findings).
  • Oversees in-house and vendor monitoring activities including selection of sites, identification of Protocol Deviations and implementation of Corrective and Preventive Actions (CAPAs).
  • Drafts, reviews and approves relevant documents including (but not limited to) informed consent, site worksheets, pharmacy manual, central laboratory manual and clinical monitoring plan along with the Program Leader's supervision.
  • Oversees study centers to ensure timely execution of the clinical studies generating quality data.
  • Offers his/her clinical input/review to clinical documents (e.g., protocols, investigator brochures, pharmacy manual, clinical study reports)
  • Provides clinical input in the development of case report forms, data management plan, and data listings review. Collaborates with Biometry to ensure timely data transfers for data cleaning, review and analysis.
  • Contributes to the review of protocol deviations and data listings to ensure integrity of data and identify trends on ongoing basis, along with the Program Leader.
  • Contributes to the resolution of escalated study conduct issues from study centers, regulatory authorities and institutional review boards (IRBs)/independent ethics committees (IECs).
  • Tracks and assists in the development of study specific timelines, including management and mitigation of deliverables.
  • Requests, distributes and updates insurance certificates for clinical studies.
  • Partners with Manager of Clinical Trial Material supplies to ensure timely manufacturing, packaging, labeling, and shipping of supplies according to regulatory/country specifications in required timeline, along with the Program Leader's supervision.
  • Monitors adherence to the regulatory/essential document collection process and release of clinical supplies.
  • Provides support in clinical product technical complaints and product recall as necessary.
  • Maintains awareness of serios adverse events (SAEs) that are reported and ensures SAE/ Suspected Unexpected Serious Adverse Reaction (SUSAR) reporting to IRB/IEC and Principal Investigators, when applicable.
  • Provides assistance in the management of the TMF process, including ongoing maintenance, accurate filing and administration of quality control (QC) plan.
  • Ensures responses to site audits are adequately managed by designated clinical staff.
  • Maintains awareness of SAEs that are reported and ensures SAE/SUSAR reporting to IRB/IEC and Principal Investigators, when applicable.
  • Provides assistance in the management of the TMF process, including ongoing maintenance, accurate filing and administration of QC plan.
  • Ensures responses to site audits are adequately managed by designated clinical staff.
  • Contributes responses to vendor/site audits, along with the Program Leader's supervision.
  • Prepares responses to internal audits, along with the Program Leader's supervision.
  • Provides support to preparation of site inspections, attends site inspections, and supports responses to site inspections, as necessary
  • Assists in the preparation of internal inspections, attends internal inspections, and contributes to responses to internal inspections, along with the Program Leader's supervision.
  • Supervises quality of the clinical trial and ensures implementation of CAPAs to quality deviations and misconducts, along with the Program Leader's supervision.

 

 

Who you are

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required

 

  • Advanced verbal, written and interpersonal skills that enable cross-functional issue resolution.
  • Advanced strategic thinking abilities for proactive planning and decisive decision making.
  • Advanced ability to set and meet deadlines, multitask, and prioritize based on program and/or study needs.
  • Advanced ability to facilitate and/or present at departmental, study, project and investigator meetings. Advanced ability to train and mentor CRAs.
  • Typically requires 8 years of experience in clinical research, including 2 years in a study management/leadership role within a pharmaceutical company.
  • Strong leadership and clinical trial/project management experience in managing study teams, vendors (e.g. CROs), and other cross-functional personnel.
  • 8+ years of experience in clinical research, including 2 to 5 years in a study management/leadership role within a pharmaceutical company.
  • Bachelor's degree in relevant scientific or medical discipline
  • Master's degree or higher-level degree in relevant discipline
  • Professional project management qualification


What we offer

It's a brilliant opportunity for someone with the right talents.
Grifols understands you want a challenging and rewarding career in a critical function such as Corporate Communications. We'll help you grow professionally.

If you're interested in joining our company and you have what it takes, then don't hesitate to apply.
We look forward to receiving your application.

Grifols is an equal opportunity employer.

Flexibility for U Program: Hybrid Model
Flexible schedule
Benefits Package
Contract of Employment: Permanent position

Company

Grifols is a global company that since 1909 has enhanced the health and well-being of people around the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative solutions and services in more than 100 countries.

Grifols Worldwide Operations Ltd. was established in 2013 in Dublin, Ireland. It serves as the management center for the global Bioscience Division overseeing treasury, risk management, supply and demand planning, regulatory, R&D and commercial functions.

It also serves as a hub for labeling, packing, final conditioning and distribution of finished plasma products to Grifols' worldwide network of commercial subsidiaries and distributors, with the exception of Spain and the United States. The site will also host an Albumin purification plant which is now under construction. www.grifols.com

Grifols Plant

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