Clinical Data Manager (6-month contract)

<meta><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;"><b><strong style="font-size:13.5pt;white-space:pre-wrap;">What You'll Do</strong></b></p><ul data-pattern="discCircleSquare" data-depth="1" style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin:8px 0px;line-height:1.6;padding:0px 0px 0px 32px;list-style-type:disc;"><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;"><span style="font-size:11.25pt;white-space:pre-wrap;">Oversees/participates in clinical data management project activities performed by vendors/CROs to ensure activities are performed with the highest quality.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;"><span style="font-size:11.25pt;white-space:pre-wrap;">Represents Zymeworks on cross-functional teams for assigned studies.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;"><span style="font-size:11.25pt;white-space:pre-wrap;">Contributes to the development/review of relevant data management documentation, including but not limited to CRFs, CRF Completion Guidelines, Data Management Plans, Edit Check Specifications, Data Review Plans, Data Transfer Specifications, etc.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;"><span style="font-size:11.25pt;white-space:pre-wrap;">Performs DM lifecycle activities, from study start-up, maintenance, database lock and close-out. Activities include, but are not limited to, CRF development, edit check specifications development, User Acceptance Testing, query management, etc.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;"><span style="font-size:11.25pt;white-space:pre-wrap;">Leads study team in the data cleaning process in an efficient and timely matter.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;"><span style="font-size:11.25pt;white-space:pre-wrap;">Understands critical tasks and milestones to ensure data management deliverables are met per study timelines.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;"><span style="font-size:11.25pt;white-space:pre-wrap;">Maintains DM metrics, timelines, meeting agendas/minutes, etc.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;"><span style="font-size:11.25pt;white-space:pre-wrap;">Contributes to the continuous improvement of CDM processes, including development/updating of SOPs and Work Instructions.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;"><span style="font-size:11.25pt;white-space:pre-wrap;">Management of third-party data and corresponding reconciliations.</span></li></ul><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;"><b><strong style="font-size:13.5pt;white-space:pre-wrap;">What You'll Bring</strong></b></p><ul data-pattern="discCircleSquare" data-depth="1" style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin:8px 0px;line-height:1.6;padding:0px 0px 0px 32px;list-style-type:disc;"><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;"><span style="font-size:11.25pt;white-space:pre-wrap;">BA or BS in a relevant field and a minimum of 8 years related experience or an equivalent combination of education and experience.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;"><span style="font-size:11.25pt;white-space:pre-wrap;">Thorough knowledge of FDA regulations, ICH GCP guidelines, Good Clinical Data Management Practices, SDTM, CDISC, database development, user acceptance testing, medical coding, the drug development process.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;"><span style="font-size:11.25pt;white-space:pre-wrap;">Previous relevant electronic systems as such EDC, IXRS, RTSM. Medidata Rave preferred.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;"><span style="font-size:11.25pt;white-space:pre-wrap;">Previous vendor/CRO oversight experience.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;"><span style="font-size:11.25pt;white-space:pre-wrap;">Preferred:&nbsp;</span></li><li style="font-size:11pt;list-style:none;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><ul data-pattern="discCircleSquare" data-depth="2" style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin-left:0px;margin-right:0px;line-height:1.6;padding:0px 0px 0px 32px;list-style-type:circle;"><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;"><span style="font-size:11.25pt;white-space:pre-wrap;">Oncology experience</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;"><span style="font-size:11.25pt;white-space:pre-wrap;">Previous experience with ePRO, SharePoint, J-Review, Business Intelligence tool</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;"><span style="font-size:11.25pt;white-space:pre-wrap;">Database development experience</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;"><span style="font-size:11.25pt;white-space:pre-wrap;">Programming experience</span></li></ul></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;"><span style="font-size:11.25pt;white-space:pre-wrap;">Proven interpersonal skills and the ability to work collaboratively as a member of cross functional team. &nbsp;Ability to establish and maintain effective working relationships.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;"><span style="font-size:11.25pt;white-space:pre-wrap;">Effective organizational skills and the ability to work effectively in a high paced, fast changing environment.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;"><span style="font-size:11.25pt;white-space:pre-wrap;">Ability to multi-task and prioritize.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;"><span style="font-size:11.25pt;white-space:pre-wrap;">Detail oriented; performs quality and accurate work.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;text-align:justify;"><span style="font-size:11.25pt;white-space:pre-wrap;">Technologically savvy; ability to quickly learn and implement new information, standards, regulations, tools, methods, or software as it relates to position and profession.</span></li></ul><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;"><b><strong style="font-size:13.5pt;white-space:pre-wrap;">Total Rewards</strong></b></p><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:left;"><span style="font-size:11.25pt;white-space:pre-wrap;">We offer a comprehensive total rewards package, which includes competitive salaries, generous benefits, an outstanding work environment, and excellent opportunities for professional growth. We regularly benchmark our compensation against leading biotechnology companies in our geographies.&nbsp;</span></p><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:left;"><br><span style="font-size:11.25pt;white-space:pre-wrap;">The base salary range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the location for which the job is posted and does not include bonus, equity, or benefits. Within the range, individual pay is determined by a variety of factors and the salary offered may vary depending on the successful candidate’s location and qualifications (including, but not limited to, job-related knowledge, education, training, skills, and experience).</span></p><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:left;"><br></p><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:left;"><span style="font-size:11.25pt;white-space:pre-wrap;">Our total rewards package that includes:&nbsp;</span></p><ul data-pattern="discCircleSquare" data-depth="1" style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin:8px 0px;line-height:1.6;padding:0px 0px 0px 32px;list-style-type:disc;"><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="font-size:11.25pt;white-space:pre-wrap;">Industry leading vacation and paid time off</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="font-size:11.25pt;white-space:pre-wrap;">Exceptional medical, dental and vision benefits by country</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="font-size:11.25pt;white-space:pre-wrap;">Zymelife health and wellness benefits</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="font-size:11.25pt;white-space:pre-wrap;">Matching RRSP / 401K / Pension program</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="font-size:11.25pt;white-space:pre-wrap;">Employee Share Purchase Program</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="font-size:11.25pt;white-space:pre-wrap;">Employee Equity Program</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="font-size:11.25pt;white-space:pre-wrap;">Paid time off to volunteer in your community</span></li></ul><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;"><br></p><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;"><span style="font-size:11.25pt;white-space:pre-wrap;">This role is not eligible for relocation or immigration support.&nbsp;</span></p><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:left;"><span style="font-size:11.25pt;white-space:pre-wrap;">&nbsp;</span></p><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:left;"><span style="font-size:11.25pt;white-space:pre-wrap;">All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin or disability.</span></p><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:left;"><span style="font-size:11.25pt;white-space:pre-wrap;">&nbsp;</span></p><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:left;"><b><strong style="font-size:11.25pt;white-space:pre-wrap;">NOTE TO AGENCIES:&nbsp;</strong></b><span style="font-size:11.25pt;white-space:pre-wrap;"> Zymeworks values our relationships with our recruiting partners. We only accept resumes from those partners who have been contracted with us. Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract. &nbsp;</span></p> <meta><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:left;"><b><strong style="font-size:13.5pt;white-space:pre-wrap;">Company Description</strong></b><br><span style="white-space:pre-wrap;">Zymeworks is a publicly listed (NASDAQ:ZYME) clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease. Zymeworks' suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop </span><span style="color:rgb(0,0,0);background-color:rgb(255,255,255);font-size:11.25pt;white-space:pre-wrap;">antibody-based therapeutic candidates</span><span style="white-space:pre-wrap;">. We are a global company headquartered in Vancouver, BC, with operations in Bellevue, WA, Dublin, Ireland, and Singapore.</span></p><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:left;"><span style="white-space:pre-wrap;">&nbsp;</span></p><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:left;"><b><strong style="font-size:13.5pt;white-space:pre-wrap;">Why Work With Us</strong></b></p><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:left;"><span style="white-space:pre-wrap;">Nothing is more critical to our success than the quality of our team. The work we do is meaningful and impactful - we care about each other as well as the patients we serve. We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.</span></p><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:left;"><br><span style="white-space:pre-wrap;">This role will be located in Bellevue, WA and is hybrid with a minimum of 3 days per week onsite.</span></p><p style="font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:left;"><br></p>