Team Lead - Study Design - Clinical Trial SaaS

Company:

CRIO (Clinical Research IO) is a health tech company helping pharma, biotech, research sites, and academic research centers streamline regulatory workflows with one system and a single source of clinical data capture. Our modules allow sites to capture data electronically in real-time, providing data managers and monitors with enhanced transparency, and enabling remote monitoring by sponsors and CROs.

CRIO’s eSource and CTMS system is a leading, modern, enterprise platform built for clinical research sites. Since CRIO’s launch in 2016, CRIO has established the leading brand position in eSource and has won close to 50% of the emerging class of enterprise-grade site networks, many of whom are backed by institutional investors such as VC, PE and corporations. CRIO has achieved the attached metrics, all with little to no serious outbound sales or marketing.

In 2022, CRIO released its Reviewer product, a separate application that allows third parties to review, query, lock, medical code and extract source data collected in eSource. Reviewer is a flexible application that CRIO plans to commercialize with its own site networks, with third party vendors (e.g., overnight EDC entry services), and with sponsors and CRO’s as either a remote monitoring tool OR a full EDC solution. This innovative architecture is truly groundbreaking, and offers a new vision for how sponsors and CRO’s can drive quality and efficiency.

Study Design Team Lead

We are seeking a highly motivated and skilled Study Design Team Lead to join our dynamic team. In this role, you will oversee day-to-day activities, including build assignments, workload management, and performance forecasting for team members. Collaboration is key, as you will work closely with Customer Success Managers and Implementation Managers to ensure project deadlines are met and troubleshoot any client build issues. Your expertise will shine as you calculate monthly metrics, contributing to department and leadership meetings. Additionally, you will play a pivotal role in providing training, education, and feedback to new hires and clients. Your collaboration with the Director of Study Design will aid in process improvement and the implementation of workflow measures to enhance efficiency. Furthermore, you will lead one-on-one weekly meetings with team members and facilitate SCRUM meetings twice a week.

Requirements

Essential Job Functions:

• Provide clear direction and guidance to the clinical study design team, setting performance expectations and fostering a collaborative working environment while assigning tasks and responsibilities to team members based on their strengths and expertise, ensuring a balanced workload
• Monitor work progress and allocate resources effectively to meet project timelines and milestones
• Foster professional growth and development within the team by providing mentorship, coaching, and constructive feedback.
• Performs quality checks on study builds to ensure consistency to the protocol, other study documentation, as well as internal standards. Will provide constructive feedback for the Study Design Builders to make improvements on future builds.
• Revises study builds according to to the clients’ comments and provide education to our clients regarding CRIO functionality during conference calls
• Lead team meetings and individual 1:1 meetings with Study Design Team Members
• Act as a liaison between the clinical study design team and other functional groups, ensuring seamless integration and alignment of efforts
• Establish and monitor key performance indicators (KPIs) to track the productivity and quality of clinical study design activities and use metrics to assess team performance and identify areas for improvement

Qualifications:

Education

• Bachelor of Science (BS) in Sciences or Medical field

Experience/Training:

• Research experience of at least 2 years
• Preferred experience in direct people management (1-3 years)

Required Skills:

• Exceptional organizational skills
• Exhibits excellent written and oral communication
• Fully autonomous to translate problems into strategic and tactical solutions
• Contributes to the internal team stakeholders to aid in day to day processes
• Committed to providing excellent customer service
• Communicates and collaborates well with other team members

• Solid time management skills to meets deadlines in a fast-paced environment
• Well organized, ability to multitask and prioritize tasks
• Strong ability to interpret clinical trial protocols and source documents
• Strong knowledge of medical terminology and procedures

Preferred Qualifications:

• Research Experience (CRC)

Benefits

Benefits

• Work from anywhere
• Coworking Reimbursement
• Lunch on us - During Training Days
• Unlimited vacation
• Unlimited sick days
• 401k company match
• Healthcare
• Dental
• Vision
• Life insurance
• Stock options
• Professional development

Equal Employment Opportunity

We’re proud to be an equal opportunity employer and welcome our employee’s differences, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or Veteran status. Difference makes us better. Join us.

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