Clinical Director of Operations
3 weeks ago
About Us
Simbec-Orion is a dynamic and innovative Contract Research Organization (CRO) with a strong focus on clinical pharmacology, oncology, and rare diseases. Our team is dedicated to delivering high-quality, tailored solutions to our clients, ensuring their clinical and commercial objectives are met.
The Role
We are seeking an experienced Associate Medical Director to join our Medical-Clinical Pharmacology team. As a key member of our team, you will be responsible for ensuring the safe execution and delivery of projects, ensuring data integrity, and maintaining the safety and welfare of trial participants.
Key Responsibilities
- Ensure the safety and welfare of trial participants and the delivery of high-quality studies in the Clinical Pharmacology Unit, in accordance with Simbec-Orion's Quality Management System, ICH-GCP, and regulatory requirements.
- Assess and develop key trial documents and reports, including study protocols, risk management plans, and study-specific training and safety reports.
- Perform screening, ongoing monitoring, and post-study clinical examinations, including review of ECGs, vital signs, and laboratory results, and manage adverse events.
- Evaluate participant eligibility and obtain written informed consent for inclusion in a specific study.
- Act as a Principal Investigator (including First in Human) or Sub-Investigator for clinical trials, actively participating in data review and taking responsibility for trial decisions.
- Provide medical cover outside of normal working hours and participate in commercial development activities, including feasibility assessment and budget reviews.
- Collaborate and consult with others to develop and maintain strong working relationships with peers, senior leaders, and key stakeholders.
Requirements
- Medical degree with GMC registration and a license to practice, with revalidation requirements met.
- Post-graduate qualification in Clinical Pharmacology or Pharmaceutical Medicine, eligible to be First-in-Human Principal Investigator.
- Experience in the conduct of clinical trials in a Clinical Pharmacology Unit and as Principal Investigator of FiH studies.
- Thorough understanding of MHRA Phase I Accreditation requirements and excellent verbal and written skills.
- Experience managing participant safety and medical emergencies, with competence in MS Office packages and understanding of client and business needs.
- Strong leadership, line management, and teamwork skills, with a valid Advanced Life Support (ALS) certificate from the Resuscitation Council (UK) and experience in leading cross-functional project/clinical teams.
Why Join Us
Simbec-Orion is a growing organization, driven by innovative new drugs in patient populations with serious unmet medical needs. As a member of our team, you will have the opportunity to contribute to cutting-edge research and development, working with a talented and dedicated team.
About Us
Simbec-Orion is a dynamic and innovative Contract Research Organization (CRO) with a strong focus on clinical pharmacology, oncology, and rare diseases. Our team is dedicated to delivering high-quality, tailored solutions to our clients, ensuring their clinical and commercial objectives are met.
The Role
We are seeking an experienced Associate Medical Director to join our Medical-Clinical Pharmacology team. As a key member of our team, you will be responsible for ensuring the safe execution and delivery of projects, ensuring data integrity, and maintaining the safety and welfare of trial participants.
Key Responsibilities
- Ensure the safety and welfare of trial participants and the delivery of high-quality studies in the Clinical Pharmacology Unit, in accordance with Simbec-Orion's Quality Management System, ICH-GCP, and regulatory requirements.
- Assess and develop key trial documents and reports, including study protocols, risk management plans, and study-specific training and safety reports.
- Perform screening, ongoing monitoring, and post-study clinical examinations, including review of ECGs, vital signs, and laboratory results, and manage adverse events.
- Evaluate participant eligibility and obtain written informed consent for inclusion in a specific study.
- Act as a Principal Investigator (including First in Human) or Sub-Investigator for clinical trials, actively participating in data review and taking responsibility for trial decisions.
- Provide medical cover outside of normal working hours and participate in commercial development activities, including feasibility assessment and budget reviews.
- Collaborate and consult with others to develop and maintain strong working relationships with peers, senior leaders, and key stakeholders.
Requirements
- Medical degree with GMC registration and a license to practice, with revalidation requirements met.
- Post-graduate qualification in Clinical Pharmacology or Pharmaceutical Medicine, eligible to be First-in-Human Principal Investigator.
- Experience in the conduct of clinical trials in a Clinical Pharmacology Unit and as Principal Investigator of FiH studies.
- Thorough understanding of MHRA Phase I Accreditation requirements and excellent verbal and written skills.
- Experience managing participant safety and medical emergencies, with competence in MS Office packages and understanding of client and business needs.
- Strong leadership, line management, and teamwork skills, with a valid Advanced Life Support (ALS) certificate from the Resuscitation Council (UK) and experience in leading cross-functional project/clinical teams.
Why Join Us
Simbec-Orion is a growing organization, driven by innovative new drugs in patient populations with serious unmet medical needs. As a member of our team, you will have the opportunity to contribute to cutting-edge research and development, working with a talented and dedicated team.
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