As the Clinical Data Manager, you will be responsible for assisting in creation and maintenance of data management, utilizing routine reports , reviewing CRF’s. The successful candidate with have excellent communication and collaboration skills, excellent critical thinking and problem solving skills with superb attention to detail.
What you’ll do
• Assist in the creation and maintenance of all essential Data Management documentation including CRF specifications, eCRFs, annotated eCRF, eCRF completion guidelines, Data Management Plans (detailing complete Data Management processes throughout clinical studies), Data Review Guidelines, Data Transfer specifications, and laboratory data handling.
• Participate in UAT plan and testing of clinical study databases along with the development of edit check specifications and manual data listings checks as required.
• Perform dataset extraction and routine report generation.
• Utilize routine reports to track study progress and ensures timeliness and quality expectations are met.
• Review CRFs, data listings, and database to ensure all captured data follow the rules outlined by the protocol and data management plan. Identifies, tracks, and resolves routine queries.
• Reconcile third party data with clinical database
• Coordinate and act as point of contact for all data operations responsibilities related to data management when designated as the Data Management Lead for the project team.
What you’ll need
Mandatory Education – Degrees, Licenses, Certifications
• Bachelor’s degree in a life science/healthcare/information technology and 2-5 years related experience, or equivalent combination of education and experience
Required Work Experience
• Minimum of 2 years relevant experience or equivalent combination of education and experience.
• Experience in oncology is an asset.
• Working knowledge of regulatory guidelines, e.g. ICH/GCP, CDISC, GCDMP, 21 CFR Part 11, and their application to Data Management practice.
• Working knowledge of MedDRA and WHO Drug data dictionaries are desirable.
• Experience with EDC systems, such as Medidata Rave EDC, Oracle InForm
• Intermediate skills and knowledge in ad hoc data reporting, data review listings, and metrics reporting.
• Technologically savvy; ability to learn quickly to and apply new information, standards, regulations, tools, methods or software as it relates to position and profession.
• Programming skills in R, SQL, SAS is an asset.
• Skills in aggregate data review and interpretation using visualization/ analysis software is an asset.
• Strong knowledge of Microsoft Office Suite.
We’re looking for
• Detail oriented
• Critical Thinking
• Organizational Skills
A little bit about us
IMV Inc. is a clinical-stage pharmaceutical company that has the potential to make history by developing a first-in-class effective T cell-targeted immune therapy for cancer. We have built an unprecedented delivery platform (DPX) that generates targeted immune cells directly into the human body, which produces robust, and sustained capabilities to destroy cancer. DPX is the engine that drives our lead drug candidate, Maveropepimut-S (DPX-Survivac), which has successfully completed multiple Phase 1/1b trials, generating best-in-class results in advanced recurrent ovarian cancer and Diffuse Large B Cell Lymphoma (DLBCL).
Our Platform Enables a Strong, Sustained Immune Response
The unique “no-release” mechanism of action of our DPX Platform allows antigen-presenting cells (APCs) to be attracted to the injection site, facilitating antigen presentation to immune cells. All our immunotherapies and vaccines candidates are formulated with the DPX platform, giving them the ability to generate, in vivo, a targeted, robust and sustained immune response against cancer cells or viruses.
Are you interested?
Work With Us
Please indicate in your application, your salary expectations and your availability for this position.
Compensation will be determined based upon skill set and experience of the selected candidate and benchmarking for the position. IMV offers paid vacation, health/ dental plan, employee assistance program, stock options, and annual bonuses.
If you feel that you are the best candidate for this position, please apply through the “Apply Now” button.
Applications will be considered upon receipt
*We appreciate your application but only candidates selected for interviews will be contacted. We reserve the right to request interview candidates to complete skill/ behavior based assessments as part of the interview process.
Strong Science Needs Bright Minds
At IMV, we have high standards. And even higher aspirations.
Our drug candidates are helping us build on this promise. Our technology provides the tools that underscore this mission. And our people are the heart of our operation-the ultimate value-drivers upon which we, as a Company, rest.
We Work Better Together
Curing diseases-especially the ones that continue to evade and outpace even the brightest minds in our industry-is hard work. Despite the intensity and ferocity of our business, the one thing we do not have to worry about is the morale and the spirit of our people. We work hard and we play hard. Our people enjoy our drive, our mission and the road less traveled. As it turns out, that does make all the difference.
We aim high with our mission, so we expect high performance from our people. Whether you are evaluating T cell responses, coordinating clinical operations with our partners, or working with our investor base, we depend on you to help realize the full value of our organization. In turn, we value you, and what you can bring to our Company. We support you in enjoying life fully while working towards your professional goals. Above all, we cultivate the camaraderie that is the hallmark of our corporate culture.Apply Now