Experience Inc. Jobs

Immediate Opening for a Clinical Project Coordinator/Business Operations Analyst *

The Business Operations Analyst, Lead specializing in data entry and analysis plays a pivotal role in ensuring accurate and timely data management for clinical trials. This role involves proficiently entering, cleaning, and analyzing data collected during clinical trials while adhering to regulatory guidelines and study protocols.

Job Responsibilities:

• Data Entry: Accurately enter clinical trial data into Sponsor Operations systems or other designated databases in a timely manner (e.g. Planisware)

• Data Cleaning: Perform data validation and cleaning procedures to ensure accuracy, completeness, and consistency of data.

• Quality Control: Conduct quality control checks on entered data to identify and resolve discrepancies or errors.

• Data Analysis: Perform analysis of clinical trial data, including generating reports, summaries, and graphical representations as required.

• Database Management: Maintain organized and up-to-date study databases, including archiving and backing up data as per regulatory requirements.

• Regulatory Compliance: Ensure compliance with regulatory guidelines, Good Clinical Practice (GCP) standards, and study protocols related to data management activities.

• Collaboration: Collaborate with other study team members, including investigators, clinical research coordinators, and statisticians, to facilitate data management and analysis processes.

• Documentation: Maintain accurate and complete documentation of data entry and analysis procedures, including data entry logs, validation checks, and audit trails.

• Training and Support: Provide training and support to study staff on data entry procedures, EDC systems, and data analysis tools as needed.

*MUST BE ON EST TIME ZONE

Will be required to travel to Japan for important meetings quarterly

Additional Skills & Qualifications:

• Bachelor's degree in a relevant field such as life sciences, statistics, or a related discipline.

• 5+ years’ experience in clinical research or data management preferred.

• Strong attention to detail and accuracy in data entry and analysis.

• Familiarity with regulatory requirements and guidelines for clinical trials (e.g., FDA regulations, ICH GCP guidelines).

• Excellent organizational and time management skills, with the ability to prioritize tasks effectively.

• Strong interpersonal and communication skills, with the ability to work collaboratively in a team environment.

• Ability to maintain confidentiality and handle sensitive information appropriately.

• Planisware experience is a strong plus

Experience Level:

Expert Level

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.