- 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; MHRA Phase I accreditation requirements and The Independent Health Care (Wales) Regulations 2011 at all times.
- Assess and develop key trial documents and reports (including study protocols, Risk Management Plans, study-specific training and safety reports) and advise/present on project safety, feasibility, and operationalisation internally and with clients.
- Perform screening, ongoing monitoring and post-study clinical examinations (including review of ECGs, vital signs, Spirometry, Holter, Laboratory results and management and assessment of adverse events) and clinical procedures as appropriate to each study (cannulation, dosing procedures, nasogastric tubes, skin biopsy samples etc.); reporting any clinically significant abnormal results and/or changes from baseline and action taken to the designated Study Principal Investigator, Senior Medical Director and/or Sponsors.
- Evaluate participant's eligibility and obtain written informed consent for inclusion in a specific study according to the information in the Investigator Brochure, Protocol and Informed Consent Document.
• Supports effective communication with volunteers' General Practitioners regarding their participation in a study, collaborative care and follow-up. - Act as a Principal Investigator (including First in Human) / Sub-Investigator for clinical trials to the highest standards, including actively participating in data review and taking responsibility for trial (including dose escalation) decisions, and liaison with hospital specialists, GPs, consultants and others to recruit suitable volunteers and patients for clinical trials.
- Be proficient in Advanced Life Support and capable of dealing with acute medical emergencies that may arise in the Clinic Pharmacy Unit. Provide medical cover outside of normal working hours as part of an On-Call Rota.
- Line Management of Research Physicians and provide leadership support and guidance to the Heads of Departments for the Clinic and Enrolment Services departments to fulfil their roles successfully; Deputise for the Senior Medical Director.
- Participate in Commercial Development activities (including Feasibility assessment and Budget reviews when required) and take an active role in providing feasibility and strategic advice for proposal development at key client meetings and Bid Defence Meetings; Represent Simbec-Orion at national and international meetings/conferences seminars and workshops.
- Collaborate and consult with others to develop and maintain strong working relationships with peers, senior leaders, and key stakeholders to ensure projects are delivered on schedule and within budget.
- Medical Degree with GMC Registered with a License to Practice and comply with revalidation requirements
- Post-graduate Qualification in Clinical Pharmacology/Pharmaceutical Medicine (eligible to be First-in-Human Principal Investigator)
- Experience in the conduct of Clinical Trials in a Clinical Pharmacology Unit
- Experience as Principal Investigator of FiH studies, including significant experience in the interpretation of non-clinical data
- Thorough understanding of MHRA Phase I Accreditation requirements
- Excellent verbal and written skills, with the ability to tailor communication to various stakeholders
- Experience managing participant safety (eligibility, ongoing review/assessment) and managing Medical Emergencies
- Competent in MS Office Packages
- Understanding and meeting the needs of clients and the business
- Strong leadership, line management and teamwork skills
- Valid Advanced Life Support (ALS) certificate from the Resuscitation Council (UK)
- Previous Bio-Tech /Pharma Experience
- Experience in leading cross-functional project/clinical teams
- Competent in using Electronic Data Capturing Systems
- Experience in business development activities, including feasibility and strategic advice for proposal development and bid-defence meetings
- Experience with Clinical Trial Management Systems (CTMS)
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Associate Medical Director - Merthyr Tydfil, Wales, United Kingdom - Simbec-Orion
Description
ABOUT US
Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers - headed up by a centralised leadership team. With a focus on tailormade and scalable solutions, we'll adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients' lives.THE ROLE We are looking for an Associate Medical Director to join our Medical-Clinical Pharmacology team. You will be responsible for ensuring that all projects are designed, executed, and delivered safely to meet clients' development needs while ensuring the safety and welfare of trial participants and data integrity within the Clinical Pharmacology Unit at all times. You will ensure that all procedures are performed to acceptable Medical, Scientific and Ethical Standards and that all trials are run in accordance with protocols and standard operating procedures (SOPs) and meet all regulatory requirements and ICH-GCP. Responsible for the line management of the Research Physician team, sharing their knowledge and supporting the team's competency. You will also act as Principal Investigator on studies including First-in-Human Trials.
KEY ACCOUNTABILITIES
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