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Senior Clinical Trial Specialist

  • Sector: Engineering
  • Contact Email: michelle.mcinerney@collinsmcnicholas.ie
  • Job Ref: 22282

We are currently partnering with a Galway based medical device start-up who are looking to hire a Senior Clinical Trial Specialist  as they expand.


Job Summary:

The Senior Clinical Trial Specialist you will be responsible for planning, executing, and overseeing clinical trials to ensure they are conducted in accordance with regulatory requirements, protocol specifications, and quality standards.


This role involves leadership, coordination of cross-functional teams, and proactive management of all aspects of clinical trial operations.


Responsibilities:

1.     Project Planning:

  • Develop and implement comprehensive project plans for clinical trials.
  • Define project timelines, milestones, and deliverables.

2.     Team Leadership:

  • Lead and coordinate cross-functional teams, including clinical research associates, data managers, and support staff.
  • Provide guidance and leadership to ensure the team meets project objectives.

3.     Regulatory Compliance:

  • Ensure adherence to regulatory requirements and guidelines for conducting clinical trials.
  • Interact with regulatory authorities as required.

4.     Budget Management:

  • Develop and manage project budgets, ensuring optimal allocation of financial resources.
  • Monitor and control expenses throughout the trial.

5.     Site Management:

  • Oversee the selection and initiation of clinical trial sites.
  • Collaborate with investigators and site staff to ensure protocol compliance.

6.     Clinical Trial Monitoring: 

  • Monitor the progress of clinical trials, identifying and addressing issues in a proactive manner.
  • Conduct risk assessments and implement mitigation strategies.

7.     Data Management:

  • Oversee data collection, analysis, and reporting activities.
  • Collaborate with data management teams to ensure data quality and integrity.

8.     Vendor Management:

  • Select and manage relationships with contract research organizations (CROs) and other vendors.
  • Ensure vendors comply with study protocols and regulatory requirements.

9.     Protocol Development:

  • Contribute to the development of clinical trial protocols.
  • Provide input on study design and methodology.

10. Quality Assurance:

  • Implement and oversee quality assurance processes to ensure compliance with Good Clinical Practice (GCP) standards.
  • Conduct internal audits and address findings.

11. Communication:

  • Communicate regularly with internal and external stakeholders, providing updates on trial progress.
  • Address inquiries from investigators, site staff, and study participants.

12. Reporting and Documentation:

  • Prepare and review study-related documentation, including clinical study reports.
  • Ensure timely and accurate reporting of trial results

Qualifications:

  • Bachelor's degree in a relevant scientific discipline; advanced degree (Master's or Ph.D.) is a plus.
  • 5 years of experience in clinical trial management within medical devices.
  • Strong knowledge of regulatory requirements and GCP standards.
  • Demonstrated experience managing cross-functional teams and external vendors.
  • Excellent communication and interpersonal skills.
  • Strong organizational and problem-solving abilities.
  • Ability to work independently and collaboratively in a fast-paced environment.

For more information and a confidential discussion on the role please contact Michelle Mc Inerney.

michelle.mcinerney@collinsmcnicholas.ie

091 706717