| Canada | General |
Lead Clinical Research Associate, Clinical Operations
|
Lead Clinical Research Associate, Clinical Operations
| Remote/virtual | 11/24/2023 12:00:00 AM | 1/1/0001 12:00:00 AM | <p><strong>About Us:</strong></p>
<p>Eupraxia Pharmaceuticals Inc. is a publicly owned novel pharmaceutical company based in Victoria, British Columbia. We are drug delivery company that focusses on delivering the right therapeutics to the right area in the right dose to improve patient lives. Our lead product candidate is an extended-release steroid intended to provide long term pain relief for patients suffering with knee osteoarthritis and we are actively expanding our portfolio of products.</p>
<p>We are looking for people that like to be part of a fast-paced, growing company that fosters creative spirit and integrated teamwork and are eligible to work within Canada.</p>
<p><strong>Job Description: </strong></p>
<p>The Lead Clinical Research Associate, Clinical Operations will oversee and ensure the appropriate operation and completion of clinical trials in selected sites.</p>
<p>They will achieve this by assessing the trial site and applicable personnel on an ongoing basis, adhering to protocol regulatory requirements, good clinical practice regulations, and standard operating procedures. They will also ensure compliance with the patient-consent processes, verifying the receipt, handling, accounting, storage conditions, and availability of clinical products under investigation. The CRA will routinely verify compliance and quality of collected data, and as necessary verify compliance with the procedures to apply in the event of serious adverse events and verify investigator records and checks for consistency with the contents of sponsor files.</p>
<p><strong>Key Responsibilities:</strong></p>
<ul>
<li>Gain an in-depth understanding of the study protocol and related procedures</li>
<li>Provide oversight of clinical monitoring activities performed by external vendors, including co-monitoring visits. Reviews and provides oversight of the clinical monitoring plan</li>
<li>Identifies objectives for scheduled monitoring visits; ensures planned visit objectives are achieved to meet protocol and SOP timelines.</li>
<li>Provides oversight of Reviews CRO-generated monitoring reports. Identify problems at sites; resolve issues and escalate as appropriate.</li>
<li>Assesses site qualification potential: reviews study requirements and pre-study evaluation reports.</li>
<li>Supports and/or leads audits/inspection activities as needed</li>
<li>Assume ambassadorial role to facilitate communication between sites and Eupraxia to increase value proposition to investigators.</li>
<li>Organize and make presentations at Investigator Meetings</li>
<li>Participates in the implementation of clinical studies; communicates with investigators and their staff; ensures compliance with terms and conditions; properly trains site personnel and writes initiation visit reports.</li>
<li>Supervises the conduct of clinical studies: acts as liaison between site personnel and the sponsor; performs monitoring in the field; ensures compliance with protocols, regulatory requirements, and good clinical practices; writes follow-up visit reports.</li>
<li>Ensures the quality of the project verifies materials and data integrity; assists site personnel with internal audits or regulatory inspections; and perform ongoing follow-up with the in-house project team.</li>
<li>Closes clinical studies verifies the integrity of investigator files; ensures availability of clinical and non-clinical materials; jointly reviews with investigators the obligations inherent at the end of the study and writes closure visit reports.</li>
<li>Maintaining awareness of overall developments in the field of clinical research.</li>
<li>Ensuring appropriate, comprehensive, and professional communications both internally and externally.</li>
<li>Actively participate in the Clinical, Regulatory, and associated business teams to build and sustain long-term working relationships across all functions.</li>
<li>Act as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement.</li>
</ul>
<p><strong>Qualifications:</strong></p>
<ul>
<li>College nursing diploma or Bachelor of health sciences, nursing, biomedical sciences, pharmacy, pharmacology, or a related discipline.</li>
<li>Master’s degree in one of the aforementioned disciplines or another postgraduate degree1 (ideal).</li>
<li>SOCRA / CCRA certification.</li>
<li>Ability to work independently, coupled with management and organizational skills.</li>
<li>Meticulous and detail oriented.</li>
<li>Bilingual (English/French ideal).</li>
<li>Proficiency in the use of the Microsoft Office Suite and specialized software for electronic databases such as CRF2, INFORM3 , e-Clinical, TrialStat, OC-RDC, etc.</li>
<li>Understanding of the regulatory context, good clinical practices, and standard operating procedures</li>
<li>Availability to travel frequently.</li>
<li>Ability to interact productively and effectively influence others.</li>
<li>Ability to set and communicate goals, and to drive efforts, overcome obstacles and achieve results within budget and timeline specifications.</li>
<li>Interpersonal and communication abilities.</li>
<li>Team building and team-oriented approach.</li>
<li>Willing to contribute at all levels.</li>
<li>High ethical standards and integrity.</li>
</ul>
<p><strong>Additional attributes:</strong></p>
<ul>
<li>Highly self-motivated </li>
<li>Able to work independently and as part of a study team</li>
<li>Detailed oriented with a view to the overall scope of the project </li>
<li>Organized</li>
<li>Accountable </li>
<li>Self-directed learner</li>
</ul>
<p><strong>Salary Range: </strong>90,000-105,000 annually</p>
<p>This is an opportunity to work in a small, entrepreneurial, and highly motivating environment, with a strong emphasis on work/life balance and a supportive company culture. We offer a competitive salary, excellent benefits, and career development opportunities.</p>
<p><strong>How to Apply</strong></p>
<p>Please send your CV and cover letter to <a href="mailto:[email protected]"><strong>[email protected]</strong></a> .</p>
<p>While only short-listed candidates will be notified, we thank each applicant for their submission.</p> |
| Canada | General |
Senior Clinical Study Manager, Clinical Operations
|
Senior Clinical Study Manager, Clinical Operations
| Remote/virtual | 11/24/2023 12:00:00 AM | 1/1/0001 12:00:00 AM | <p><strong>About Us:</strong></p>
<p>Eupraxia Pharmaceuticals Inc. is a publicly owned novel pharmaceutical company based in Victoria, British Columbia. We are drug delivery company that focusses on delivering the right therapeutics to the right area in the right dose to improve patient lives. Our lead product candidate is an extended-release steroid intended to provide long term pain relief for patients suffering with knee osteoarthritis and we are actively expanding our portfolio of products.</p>
<p>We are looking for people that like to be part of a fast-paced, growing company that fosters creative spirit and integrated teamwork and are eligible to work within Canada.</p>
<p><strong>Job Description: </strong></p>
<p>The Senior Clinical Study Manager is responsible for the oversight, execution and success of Eupraxia clinical studies. The Study Manager works cross-functionally with internal functional leads and external contract research organizations (CROs) to ensure that studies are completed to agreed standards, timelines and budget. The role will develop and support the work of Eupraxia’s clinical operations across a range of products and in accordance with company policies, procedures and culture.</p>
<p><strong>Key Responsibilities:</strong></p>
<ul>
<li>Serve as primary internal and external contact for clinical studies. Attend all study team calls and ensure effective communication between external vendors and Eupraxia staff.</li>
<li>Ensures delivery of key clinical trial milestones in compliance with the agreed budget, scope and timelines and in accordance with applicable SOPs, GCP, regulatory and any trial-specific requirements,</li>
<li>Initiate and participate in the early planning phases of clinical study by providing guidance on deliverables and options, such as preparation of initial timeline and budget assumptions, human resource requirements, essential study documentation, etc.</li>
<li>In collaboration with Outsourcing, Clinical and Quality Assurance, supports the identification, qualification, selection and contracting process for new clinical trial vendors.</li>
<li>Develops, Inputs, reviews and coordinates Eupraxia’s team review of trial-specific documents (e.g., Project Management Plan, Data Validation Plan, Pharmacovigilance plan, etc).</li>
<li>Provide oversight of other Clinical Operations staff (e.g., Clinical Trial Assistants, Lead Clinical Research Associates) assigned to the clinical trial. Coordinate with other cross-functional Eupraxia staff to achieve study goals and corporate priorities.</li>
<li>Retains overall responsibility for trial performance. Monitors study metrics and key performance and risk indicators. Escalate issues and proactively identify and address risks.</li>
<li>Oversees activities related to site selection (feasibility questionnaires, sites selection, planning of site qualification visits) and patient recruitment (monitors recruitment status, follows-up on recruitment strategy plan).</li>
<li>Participates in generation and review of regulatory submission documents.</li>
<li>Oversees internal and outsourced activities related to central ethics submissions.</li>
<li>Ensures contracted vendors collect required essential documents from sites prior to study initiation.</li>
<li>Participates in the planning and execution of Investigator’s Meetings and Site Initiation Visits.</li>
<li>Oversees contracted vendor’s performance of clinical monitoring activities for site qualification, initiation, routine and close-out visits. Reviews monitoring visit reports, site visit follow-up letters, centralized monitoring outputs, performs co-monitoring visits as necessary.</li>
<li>Ensures that the Trial Master File (TMF) is complete and accurate.</li>
<li>Provides regular status updates to internal stakeholders.</li>
<li>Maintain current training with Good Clinical Practice and Eupraxia Standard Operating Procedures (SOPs) related to clinical operations activities.</li>
<li>Maintain awareness of overall developments in the field of clinical research and contribute to continuous improvement of the clinical procedures. </li>
<li>Enact and track proper onboarding of new Eupraxia staff to clinical projects.</li>
<li>Maintain excellent relationships with research sites, pharmaceutical partners and suppliers in clinical development programs to optimize delivery.</li>
</ul>
<p><strong>Qualifications:</strong></p>
<ul>
<li>Relevant university degree and 7+years of management/leadership experience across all clinical phases of global drug development and in multiple therapy areas.</li>
<li>In-depth knowledge of the drug development process, clinical development planning, clinical research methodologies and execution, and core regulatory requirements for CA, USA and EU.</li>
<li>Direct hands-on experience in managing high-quality, successful global clinical trials to agreed scope, timelines and budget.</li>
<li>Successful experience in coordinating internal and external resources for multi-county clinical development and in working internally with core functions and externally with strategic partners.</li>
<li>Experience of working in a matrix environment.</li>
<li>Experience of, and successfully operated within a small pharma / CRO environment, with high moving and in dealing with multiple priorities and tight timelines.</li>
<li>Ability to interact productively and effectively influence others.</li>
<li>Ability to set and communicate goals, to drive efforts, overcome obstacles and achieve results within budget and timeline specifications.</li>
<li>Interpersonal and communication abilities.</li>
<li>Team building and team-oriented approach.</li>
<li>Willing to contribute at all levels.</li>
<li>High ethical standards and integrity.</li>
</ul>
<p><strong>Additional attributes:</strong></p>
<ul>
<li>Highly self-motivated </li>
<li>Able to work independently and as part of a study team</li>
<li>Detailed oriented with a view to the overall scope of the project </li>
<li>Organized</li>
<li>Accountable </li>
<li>Self-directed learner</li>
</ul>
<p><strong>Salary Range: </strong>100,000-115,000 annually</p>
<p>This is an opportunity to work in a small, entrepreneurial, and highly motivating environment, with a strong emphasis on work/life balance and a supportive company culture. We offer a competitive salary, excellent benefits, and career development opportunities.</p>
<p><strong>How to Apply</strong></p>
<p>Please send your CV and cover letter to <a href="mailto:[email protected]"><strong>[email protected]</strong></a> .</p>
<p>While only short-listed candidates will be notified, we thank each applicant for their submission.</p> |
| Canada | General |
Senior Director Medical Affairs
|
Senior Director Medical Affairs
| Remote/virtual | 11/14/2023 12:00:00 AM | 1/1/0001 12:00:00 AM | <p><strong>About Us:</strong></p>
<p><span style="font-weight: 400;">Eupraxia Pharmaceuticals Inc. is a publicly owned novel pharmaceutical company based in Victoria, British Columbia. We are drug delivery company that focusses on delivering the right therapeutics to the right area in the right dose to improve patient lives. Our lead product candidate is an extended-release steroid intended to provide long term pain relief for patients suffering with knee osteoarthritis and we are actively expanding our portfolio of products. </span></p>
<p><span style="font-weight: 400;">We are looking for people that like to be part of a fast-paced, growing company that fosters creative spirit and integrated teamwork and are eligible to work within Canada.</span></p>
<p> </p>
<p><strong>Job Description: </strong></p>
<p><span style="font-weight: 400;">The Director, Medical Affairs will be responsible for defining and implementing KOL strategies to develop and maintain positive KOL endorsement and product champions for Eupraxia in OA diseases. The role will also be responsible for leading Eupraxia medical education initiatives and conference activities.</span></p>
<p> </p>
<p><strong>Key Responsibilities:</strong></p>
<ul>
<li style="font-weight: 400;"><span style="font-weight: 400;">The role will develop and execute KOL strategies required to prepare the market for Eupraxia EP-104IAR (pre-approval) and to position the product and the company as a leader in OA arena.</span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">Pre-approval, a primary goal for this role will be to identify, engage and develop key opinion leaders (KOLs) in the OA therapeutic area across the US and EU and as requested in the broader Americas [Canada, Mexico], and in all subsequent target indications. </span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">Post approval the focus will be to further develop these relationships.</span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">Working with operations management, the Medical Affairs and Clinical/Regulatory teams, the position will </span></li>
<ul>
<li style="font-weight: 400;"><span style="font-weight: 400;">Define the US KOL strategy including activities involving KOLs at international congresses, Advisory Boards and National/Regional meetings. </span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">Develop KOLs and communicate the evidence base supporting EU-104IAR and subsequent programs. </span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">Once the strategy has been developed, the Head, Medical Affairs will be responsible for the implementation of these tactics, working in cooperation with the Clinical Team. </span></li>
</ul>
<li style="font-weight: 400;"><span style="font-weight: 400;">This role will support the development and maintenance of positive relationships and interaction with key advocacy groups, as part of the pre-approval market development required for a successful launch.</span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">The Head Medical Affairs will be a pivotal interface between the product management team, the Medical Affairs team, and Clinical colleagues to ensure a coordinated approach to interacting with KOL’s, advocacy groups and other 3rd party groups.</span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">In conjunction with the responsibilities above, they will assist in the development of a KOL contact management database for all Eupraxia employees (medical /regulatory/commercial). The job holder will coordinate as necessary to maintain and keep the system current.</span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">Build out and lead the Medical Affairs function to support commercial launches of Eupraxia’s new products into the marketplace. Partner with Commercial to ensure timely, accurate, and compliant preparation and review of promotional and educational material.</span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">Establish and execute a strategic publication and congress plan; work with internal colleagues to develop key messages on unmet need, mechanism of action, target product profile, and among others.</span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">Partner with Clinical Operations and Clinical Development to facilitate enrollment of company sponsored clinical trials.</span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">Work collaboratively with all appropriate cross-functional colleagues (e.g. clinical, regulatory, legal and market access)</span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">Foster an environment of compliance and integrity by managing and adhering to all company policies and Legal and Regulatory guidelines. As necessary, the Head Medical Affairs will contribute to the development of Medical Affairs/Commercial budgets</span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">Be responsible for managing to the approved budgets</span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">Other ad hoc duties and assignments as requested for the overall performance of the function and the company.</span></li>
</ul>
<p> </p>
<p><strong>Qualifications:</strong></p>
<ul>
<li style="font-weight: 400;"><span style="font-weight: 400;">The ideal candidate will have a demonstrated expertise in Medical Affairs with KOL’s and advocacy organisations. This is likely to be at least 5 years of experience gathered in either/and Pharmaceutical Industry / agencies. </span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">A track record of identifying and developing Key Opinion Leaders (preferably within/for the US).</span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">Evidence of direct experience of developing and interacting with patient advocacy groups.</span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">The individual will have a medical degree or advanced degree in the health sciences. </span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">Commercial launch experience would be an advantage</span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">Understanding of OIG, PhRMA, & ACCME guidelines.</span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">Has experience of using and developing contact management databases.</span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">Experience in the therapeutic area of osteoarthritis/musculoskeletal disorders, gastrointestinal disease or oncology diseases would be an advantage.</span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">The position requires significant travel (may be approximately 20 - 25% but as needed to fulfill the positions’ responsibilities).</span></li>
</ul>
<p> </p>
<p><strong>Additional attributes:</strong></p>
<ul>
<li style="font-weight: 400;"><span style="font-weight: 400;">Ability to maintain a high level of confidentiality.</span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">Exercise excellent customer service skills.</span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">Excellent communication and time management skills and possess a high level of organizational ability.</span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">Attention to detail due to various factors affecting contract entitlements.</span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">Possess troubleshooting, problem solving, and creative/innovative thought processing skills.</span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">Understand office formats and procedures.</span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">Demonstrated leadership skills and ability to document and implement processes and procedures. </span></li>
<li style="font-weight: 400;"><span style="font-weight: 400;">Self motivated and self-directed</span></li>
</ul>
<p><span style="font-weight: 400;">This is an opportunity to work in a small, entrepreneurial, and highly motivating environment, with a strong emphasis on work/life balance and a supportive company culture. We offer a competitive salary, excellent benefits, and career development opportunities. </span></p>
<p><strong>How to Apply</strong></p>
<p><span style="font-weight: 400;">Please send your CV and cover letter to </span><a href="mailto:[email protected]"><span style="font-weight: 400;">[email protected]</span></a><span style="font-weight: 400;"> .</span></p>
<p><span style="font-weight: 400;">While only short-listed candidates will be notified, we thank each applicant for their submission. </span></p> |