- Opportunity to join a talented team in a fast-paced medical technology company
- Reporting to the Executive Vice President – Marketing
- A public company with global clients
Covalon is currently seeking a motivated, energetic and results oriented Clinical Manager responsible for the management and oversight of both the operational aspects of high quality clinical studies and the development, deployment, and management of all clinical and product training initiatives. The right candidate for this role will have a Bachelor of Science Degree with at least 5 years experience in recruiting investigators and managing clinical trials from start to finish and at least 3 years of experience developing, implementing and managing device related training programs and/or curriculums. Some competencies for this role include the ability to work both independently and within teams, demonstrated project management skills, attention to detail, organized and able to manage competing priorities, and exceptional verbal and written communication skills.
This is a unique opportunity and the role can be designed to fit the strengths and interests of the right candidate. We offer competitive remuneration with an opportunity for bonuses and full benefits.
- Identifies, screens, and selects Principal Investigators to deliver against defined clinical study planning objectives.
- Responsible for creating and executing training programs based on education needs identified by organizational leadership.
- Supports delivery of clinical programs and trials by collaborating with team members and stakeholders locally and globally.
- Lead and coordinate facilitation of training courses and/or programs based on sound adult learning principles and identified business needs.
- Partners with internal stakeholders to develop strategic plans to maximize the effectiveness of new product launches and necessary training.
- Supports Principal Investigator’s staff by providing training and advice relating to Covalon’s technologies and products.
- Creates and maintains realistic project and study plans (including timings and total costs) in agreed systems.
- Ensures studies are submission-ready and acts as primary point-of-contact between Covalon and clinician.
- Manages clinical trials from start-up to close-out, ensuring study conduct is in compliance with appropriate SOPs, ICH-GCP, HSP guidelines and regulatory requirements.
- Collaborates with internal team members and external trial counterparties to ensure study deliverables are on-track to achieve agreed-upon protocol timelines.
- Develops clinical trial budgets, negotiates contract payment terms and analyzes remaining budget on a quarterly basis ensuring achievement of overall study budget.
- Represents Covalon at meetings, reviews, and symposia that may require international travel and overnight stays.
- Act as a change agent by assisting in the influence, and subsequent implementation of new clinical guidelines, protocols, policies, and procedures.
- Be current and knowledgeable with the literature related to new research in the categories and segments in which Covalon operates.
- Provide operational expertise in creating, designing and reviewing of critical and essential study documents such as a clinical study protocol, informed consent forms (ICF), and clinical study report, etc.
- Work closely with QA, regulatory representatives and peers to support investigations and documentation related to deviations and/or CAPA report preparation, review, finalization, and implementation.
- University degree in medical, biological sciences or health science; graduate degree is preferred
- Project management certification would be considered an asset.
- At least 5 years’ experience in recruiting investigators and managing clinical trials
- Extensive knowledge of clinical trial operations/management, project management
- Strong stakeholder management skills
- Excellent communication and relationship building skills
- Knowledge of process improvement methodology and change management techniques
- Professional accreditation would be an asset (CCRA, CCRP)
- Knowledge of ICH-GCP, HSP guidance and regulatory requirements
- Experience in clinical quality and compliance. Clinical trial audit experience would be considered an asset.
- Proven experience with vendor interaction including commitment and customer/stakeholder focus
- Proven negotiation, interpersonal, and organizational skills
- Demonstrated effective organizational and time-management skills
- Broad knowledge about the medical device industry is an asset
- Demonstrated ability to work with MS Office products
- Ability to travel internationally.
If you are the right person for us and you think we may be the right people for you, please apply, including a cover letter telling us why you’d be perfect for this career opportunity. This is an opportunity to sell us! Please contact firstname.lastname@example.org