Senior Clinical Data Manager - 1423 - Seattle, WA | Biospace
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Senior Clinical Data Manager - 1423

Zymeworks Inc

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Location:
Seattle, WA
Posted Date:
7/13/2017
Position Type:
Full time
Job Code:
1423
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Clinical Data Management,

Job Description

Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation 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.
Zymeworks is seeking a highly motivated professional who is looking to grow their career with our company. This position will be based in Seattle and will report to the Director, Clinical Operations.

Key Responsibilities:
Provides clinical data management support to the Clinical operations team and/or study project ensuring the delivery of high quality data from project start-up to project execution and close-out.

Develops and/or is accountable for the Data Management Plan, maintaining the plan throughout the lifecycle of study project and ensuring it is followed in accordance with study design and requirements.

Performs and/or is accountable for clinical database setup, testing, maintenance and data quality control functions through database lock in accordance with GCP, ICH and SOPs. Ensures data system compliance by following the established guidelines of national and international regulatory authorities

Performs and/or is accountable for data management study start-up activities including CRF/eCRF design; developing database specifications; defining validation specifications, edit rules/checks, query logic, data validations and user acceptance testing.

Performs and/or is accountable for all data management activities such as data collection and entry, database access requirement implementation, data cleaning, training, and/or other tasks associated with the clinical trial database.

Participates in the review of clinical research documents (eg. Protocols, Case report Forms, Reports and Statistical analysis).

Participates in internal/sponsor meetings and training programs as required, works directly with assigned project manager and team to provide data management support.

Provides oversight and management of all relevant clinical data interactions with CROs.
Ensures approved study documentation is maintained and properly stored in the trial master files.

Communicates project status updates and key project issues to management on a regular and timely basis.

Manages project resources according to budget and within timeframes.

Fosters effective and collaborative working relationships with fellow employees, management and external partners.

Requirements

University degree in a health-related field and a minimum of 5 to 7 years’ related experience within the pharmaceutical industry or an equivalent combination of education and experience.

Skills and Abilities:

Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team. Ability to establish and maintain effective working relationships.

Clinical or medical knowledge and skills required, oncology research specific knowledge and experience preferred.

Working knowledge of GCP, GMP, clinical research, clinical trial process and related regulatory requirements and terminology.

Proficient with clinical database applications such as Medidata RAVE and report tools.

Experience with working on Phase I-IV study trials.

Excellent organizational skills and the ability to work effectively in a high paced, fast changing environment.

Good project coordination skills and effective oral and written communication skills.

Strong attention to detail and good analytical skills.

Proficiency with MS Office.