Provide administrative support to clinical trial teams, including the maintenance of essential trial documents and eTMF quality control. Track study conduct metrics and collaborate with cross-functional teams to ensure trial milestones are met.
Requirements summary
Requires a Bachelor's degree in biology, chemistry, or health sciences with 1-3 years of clinical research experience. Candidates should have a basic knowledge of FDA GCP guidelines and proficiency in MS Office.
What You'll Do Provide administrative support to clinical trial teams.
Assist in the preparation and maintenance of essential trial documents.
Organize internal study team meetings and issue agendas/minutes (with approval from CTM).
Assist and support eTMF Manager in QC of eTMF.
Set up and ensure all study-related documents are filed per folder structure on internal filing repository (Sharepoint).
Assist CTM in keeping internal study conduct tracker, and any other oversight trackers up-to-date.
Maintain study conduct metrics, including but not limited to study start up timelines, enrollment rates, screen-failure rates and deviation rates.
Monitoring review oversight of external vendor.
Patient data review in collaboration with cross-functional teams and external vendor.
Assist in reviewing invoices, including pass-throughs, referring to site agreements, patient enrollment and/or monitoring visit trackers.
Carry out the function of the role in compliance with company Standard Operating Procedures (SOPs), working practices and regulatory guidelines.
Foster effective and collaborative working relationships with cross-functional teams and management globally to ensure trial milestones are met.
Promote timely and accurate communication amongst the internal and external teams.
Serves as back-up to the CTM, when needed.
What You'll Bring Bachelor’s degree preferably in the field of biology, chemistry or health sciences and 1-3 years’ previous clinical research experience.
Prior Clinical Trials Associate experience in oncology preferred.
Proven interpersonal skills with the ability to work collaboratively as a member of cross-functional and global team.
Ability to establish and maintain effective working relationships.
Good organizational skills and the ability to work effectively in a high paced, fast changing, compliance-driven environment.
Results-oriented and flexible attitude.
Ability to track and manage key dates/deadlines.
Basic knowledge of drug development and FDA GCP regulatory guidelines.
Benefits
Dental Benefits
Vision Benefits
Medical Benefits
Professional Growth Opportunities
Competitive Salaries
Vacation And Paid Time Off
Familiarity with FDA/ICH regulatory requirements for clinical trials is desired.
Excellent oral and written communication skills, with particular attention to detail.
Ability to appropriately handle confidential information.
Proficiency with MS Office and Excel.
Total Rewards 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.
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).
Our total rewards package that includes
Industry leading vacation and paid time off Exceptional medical, dental and vision benefits by country This role is not eligible for relocation or immigration support. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin or disability.
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AGENCIES: 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.
