Job Description

Responsibilities:

Clinical Data Manager, you will play a key role in providing oversight to ensure complete, accurate and high-quality data collection for outsourced and in-house trials.
Establish and maintain strong relationships with internal cross-functional teams, vendors and clinical research site personnel for successful execution of clinical trial.
Lead and oversee Electronic Data Capture (EDC) build, migration and deployment including creation and execution of user acceptance testing plans and test scripts, and implementation of data integrations with external vendor data sources (e.g., IRT, laboratory, imaging).
Oversee set-up of other clinical management systems (e.g., IxRS) and data transfer agreements with external vendors.
Write or contribute to preparation of CDM documents.
Lead the development of EDC custom and Business Objective reports, SAS clinical programming report specifications and data visualization output.
In collaboration with Study Execution Team, participate in clinical document review such as clinical protocols, statistical analysis plans, protocol deviation plans, mock tables, figures and listings.
Report Data Management metrics and trends; identify barriers to timely and successful trial execution and propose solutions.

Requirements:

Bachelor's Degree in life sciences or related discipline.
6+ years of experience in clinical data management or relevant work experience.
CRO or CDM vendor management experience in oncology.
Early phase adaptive trial management experience preferred.
Experience with CDASH terminology and/or MedDRA and Who Drug medical coding.
Experience with SAS programming techniques is a plus.
Experience with RaveX and/or Veeva EDC is a plus.
Experience with Spotfire is a plus.
Strong working knowledge of CDISC standards, FDA and ICH/GCP regulations and guidelines.
Proficient on EDC configuration and design, testing and validation, data collection and data review process, and data standardization.
Self-motivated and takes pride in your work.

Katalyst HealthCares and Life Sciences

Job Tags

Work experience placement,

Similar Jobs

Scenthound Austin, TX

Dog Bather Job at Scenthound Austin, TX

...Opportunity for advancement Training & development ABOUT THE POSITION: Are you ready for a change? Interested in hanging out with dogs all day? We are looking for passionate dog lovers to become bathers at our Westlake location on Bee Cave Rd in Austin. New to...

The University of Vermont Health Network

Licensed Practical Nurse - Med/Surg Job at The University of Vermont Health Network

...of $10,000 (gross amount, prorated for part-time roles) which requires a 2 year commitment. Relocation benefits may be available for relocating candidates. A relocation package of $5,200 (pro-rated for part-time roles) is also available for relocating applicants. Please...

The Human Bean

Coffee Barista Job at The Human Bean

...Prepare and serve a variety of hot and cold beverages, including coffee, tea, and specialty drinks - Take customer orders and provide... ...established a reputation for having friendly and experienced baristas and offering the highest quality ingredients. The Human Bean

South Shore Health

RN Registered Nurse IMCU Stepdown Part Time Job at South Shore Health

...SSH IMCU Pratt 6 South Status Part time Budgeted Hours 24 Shift Varied... ...Manages individualized, outcome oriented nursing care through the use of the nursing process... ...Required Licenses/Certifications RN - Registered Nurse Depending on department Basic...

Donor Network of AZ

Donation and Family Advocate Job at Donor Network of AZ

...Donation and Family Advocate *To BeConsidered for this Role, you must Submit a Cover Letter* Aboutthe Team We are looking for dedicated individuals, excited to be a part of our culture! Donor Network of Arizona's mission is to make the most of life through the...

Clinical Data Manager Job at Katalyst HealthCares and Life Sciences, San Diego, CA

Nm5lRnVlZkh0Qk1SbVhsNGxFVkZrNWRVK1E9PQ==