COMPANY PROFILE
Our client is a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease. Their research is centred around harnessing the potential of CBD to mitigate inflammation and fibrosis associated with heart disease, aiming to offer a novel and effective therapeutic solution. Their lead small molecule drug candidate is pharmaceutically manufactured and in clinical development for use in the treatment of heart disease.
JOB SUMMARY
Reporting directly to the Senior Director of Clinical Operations, the Clinical Trial Manager will be responsible for the strategic planning, execution, and supervision of clinical trials, ensuring strict adherence to protocols, regulatory guidelines, and quality standards. As the primary point of contact for cross-functional teams, investigators, and regulatory authorities, the Clinical Trial Manager will leverage their excellent communication and project management skills to drive the successful progression of trials from initiation to completion.
If you are a dedicated professional with a strong background in clinical trial operations, cardiology, and a passion for advancing medical research, we invite you to apply and contribute to improving healthcare outcomes for patients with heart disease.
RESPONSIBILITIES:
- Leads and manages clinical studies to ensure studies are conducted in accordance with approved scope of work and budget, regulatory guidelines and within established timelines.
- Manages and liaises external clinical study vendor partners, including data management, biostatistics, central laboratories, and investigational products.
- Participate in contract negotiations as required.
- Provides input into clinical study documents including protocols, ICF templates, patient diaries, study budgets, site log/form templates, study manuals and plans, site binders and study reports.
- Serves as study lead and primary contact for both internal and external stakeholders.
- Drives and facilitates teamwork across internal and external clinical operations.
- Ensures accuracy of documented work products
- Lead/participate and present at project meetings.
- Generates and presents study status updates and reports.
- Leads and manages CRO partners to ensure high quality and timely delivery of study deliverables.
- Manages site and investigator accrual, retention and compliance to optimize trial recruitment.
- Participates in contract negotiations with clinical sites as required.
- Ensures that the study Trial Master File is up to date and assists in the management of audits as needed.
- Proactively identifies issues and risks and develops problem-solving strategies to address hurdles to study deliverables.
- Quality and Regulatory
- Ensures compliance with ICH GCP, and external regulatory agency requirements including FDA, HC, EMA, and corporation's internal SOPs.
- Participates in third-party audits and regulatory agency inspections.
- Initiates, reviews, and updates SOPs as required.
- Participates in and/or leads SOP training as required.
QUALIFICATIONS:
- University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research.
- Minimum 3 years experience within the pharmaceutical industry supporting clinical operations.
- Proven project management, organizational and analytical skills.
- Knowledge of clinical development and drug development process across various phases and therapy areas as well as relevant knowledge of GCP Computer proficiency.
- Strong knowledge of cardiology or related therapeutic areas.
- Demonstrated leadership abilities in a cross-functional, multi-disciplinary team environment.
- Excellent written and verbal communication skills.
- Demonstrated strategic planning and problem-solving skills.
- Effective project management and people management skills.
- A background in nursing is considered an asset.
Thank you in advance for your interest, only individuals deemed to have the skill set and experience to fit the role will be contacted.
Lock Search Group is a National Executive Recruitment firm with 11 offices in Canada and one in the United States, a staff of more than 30 Consultants and Associates, and expertise in 11 major disciplines. Our mission is to provide exceptional Recruitment and Consulting Services to clients and candidates. We apply our experience and expertise to deliver solutions with a personalized approach that focuses on client needs and candidate goals.
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Represented by Abigail Van Riesen, PhD – Scientific Recruitment Consultant
avanriesen@locksearchgroup.com | 519.222.6474
