Clinical Data Manager Job at BioTalent Canada, San Francisco, CA

U0xWaytJem1JeGMyNldrbndTSm5yeXFDeEE9PQ==
  • BioTalent Canada
  • San Francisco, CA

Job Description

Workplace Type: Hybrid

Zymeworks is a publicly listed (NASDAQ:ZYME) clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation, bispecific and multifunctional biotherapeutics, initially focused on the treatment of cancer. Zymeworks’ suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly-differentiated product candidates.

Why Work With Us:

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.

Zymeworks is proudly headquartered in our brand new, net-zero facility located in the vibrant Main St biotech hub of Vancouver, BC, with operations in Bellevue, WA, Dublin, Ireland, Singapore and the Bay Area.

About the Position:

Zymeworks is seeking a Clinical Data Manager to contribute to Clinical Data Management activities. This role will complete data management tasks with a high degree of quality in accordance with regulatory requirements and Zymeworks’ timelines. The Clinical Data Manager will have a thorough knowledge of FDA regulations and industry standards, strong technical skills, and capable of working independently and collaboratively, in addition to providing oversight of CRO activities.

This position is open to qualified candidates in our San Francisco hub (Redwood City) and is eligible for our Hybrid Work Plan (3 days per week in office). The role will report to the Director, Data Management.

Key Responsibilities:

  1. Oversees/participates in clinical data management project activities performed by vendors/CROs to ensure activities are performed with the highest quality.
  2. Represents Zymeworks on cross-functional teams for assigned studies.
  3. 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.
  4. 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.
  5. Leads study team in the data cleaning process in an efficient and timely manner.
  6. Understands critical tasks and milestones to ensure data management deliverables are met per study timelines.
  7. Contributes to the continuous improvement of CDM processes, including development/updating of SOPs and Work Instructions.
  8. Management of third-party data and corresponding reconciliations.

Education and Experience:

  1. BA or BS in a relevant field and a minimum of 8 years related experience or an equivalent combination of education and experience.
  2. 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.
  3. Previous relevant electronic systems such as EDC, IXRS, RTSM. Medidata Rave preferred.
  4. Preferred:
  5. Previous experience with ePRO, SharePoint, J-Review, Business Intelligence tool.
  6. Programming experience.

Skills and Abilities:

  1. Proven interpersonal skills and the ability to work collaboratively as a member of cross-functional teams. Ability to establish and maintain effective working relationships.
  2. Effective organizational skills and the ability to work effectively in a high-paced, fast-changing environment.
  3. Ability to multi-task and prioritize.
  4. Detail-oriented; performs quality and accurate work.
  5. Technologically savvy; ability to quickly learn and implement new information, standards, regulations, tools, methods, or software as it relates to position and profession.

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 US base salary range for this full-time position is $113,000 – $173,000 + bonus + equity + benefits. Our salary ranges are determined by role, level, and location.

The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. 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).

Please note that the compensation details listed in role postings reflect the base salary only, and do not include bonus, equity, or benefits.

Additional Benefits:

  • Industry-leading vacation and paid time off
  • Excellent health and wellness benefits
  • Zymelife health and wellness benefits
  • Paid time off to volunteer in your community
  • Matching country-specific pension savings program
  • Employee Share Purchase Program
  • Employee Equity Program

All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin or disability.

NOTE TO 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.

#J-18808-Ljbffr

Job Tags

Full time, Contract work, 3 days per week,

Similar Jobs

Northern Impact

Fashion Stylist | High-End Luxury Retail Job at Northern Impact

Overview Fast-growing luxury brand is seeking a Stylist for their retail store located in Hinsdale & Chicago (Gold Coast), Illinois. Fashion Stylist responsibilities include providing one-on-one customer service, recommending fashionable items, and creating complete...

Heart2Heart HHC Inc.

Home Health Care Assistant/Certified Nurses Assistant (CNA) Job at Heart2Heart HHC Inc.

 ...Scheduling Competitive Compensation Career Advancement Job Summary We are seeking experienced home health care professionals/Certified Nursing Assistants (CNA) to join our team. In this position, you will assist patients with their daily living needs, provide... 

Adecco

Programmatic Advertising Sales Manager Job at Adecco

 ...Description Job Description Company: Confidential Location: Remote (Worldwide) Industry: Programmatic Advertising / SaaS...  ...segments, and targeting, the company expanded to provide fully managed programmatic advertising services across North America. In 2023... 

Nike

Retail Associate, PT Job at Nike

Become a Part of the NIKE, Inc. Team NIKE, Inc. does more than outfit the world's best athletes. It is a place to explore potential, obliterate boundaries and push out the edges of what can be. The company looks for people who can grow, think, dream and create. Its... 

Software Technology, Inc

ETL Datastage Developer - MN-MINNETONKA Job at Software Technology, Inc

 ...Location : MN-MINNETONKA No. of Positions: 2 Duration: 1 Year + Experience: 7+ Year Contract to hire Mandatory Skills : IBM Datastage, Teradata, SQL, Unix We need only USC / GC/ EAD / TN candidates for this role. Job description : Strong...