Clinical Data Coordinator

COMPANY BACKGROUND

Akero Therapeutics is a clinical stage biopharmaceutical company focused on discovering and developing transformational treatments for patients with serious metabolic diseases marked by high unmet need. Our current focus is on advancing our lead program efruxifermin (EFX) to provide a powerful new treatment for patients with MASH(metabolic dysfunction-associated steatohepatitis).

We are a team of problem solvers dedicated to pursuing bold scientific approaches to build a brighter future for patients. Our diverse skill sets and backgrounds, desire to learn from each other and collaborative spirit breed a culture where everyone feels inspired to bring their best thinking to work, and to bring out the best in others.

Job Summary: We are seeking an experienced and detail-oriented Clinical Data Coordinator to join our team. The ideal candidate will have at least 3 years of experience in clinical data management, with a strong preference for those with experience in MASH (Metabolic-Associated Steatohepatitis) clinical trials. This role involves managing and ensuring the accuracy and integrity of clinical data collected during trials.

Key Responsibilities:

• Perform reviews of clinical trial data through external data listings to ensure all captured data follows the rules outlined by the protocol and Data Management Plan
• Review responses to queries for appropriateness and resolves any discrepancies
• Provide input to and review of data management documents in support of clinical study deliverables
• Maintain data cleaning status with respect to key performance indicators, metrics, and program level deliverables and timelines
• Work proactively with team members to identify risks and execute risk mitigation strategies
• Prepare and submit data reports for clinical and medical operations
• Contribute to program deliverable timeline creation and project re-forecasting
• Support the development of CRFs and edit check specifications per protocol and participate in user acceptance testing of CRFs and associated edit check specifications as required

Technical Requirements & Skills

• Ability to handle multiple studies within a program
• Familiarity in handling multiple sources of data (external vendor data)
• Good analytical skills and demonstrated experience in gathering, interpreting and analyzing data in clinical research and drug development
• Understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies required
• Flexible to changing priorities and study demands

Qualifications:

• Bachelor's degree in a relevant field (e.g., Life Sciences, Health Information Management, or other closely related field).
• Minimum of 3 years of experience in clinical data management with experience with MASH clinical trials is highly preferred.
• Strong knowledge of medical terminologies and drug classifications
• Proficiency in using data management systems and software. Rave experience is required.
• Excellent attention to detail and problem-solving skills.
• Strong communication and collaboration skills.

Compensation: 

• Below is the pay range for this position that we reasonably expect to pay. Individual compensation is based on a number of factors including, experience, education and skill set, and geographic location. This range is for the San Francisco Bay Area, California location and may be adjusted to the labor market in other geographic areas. 

  Pay range: $90,000 - $110,000 per annum