RTSM Study Project Lead - Level 1 (Biotech)

4G Clinical LLC.; Portland (OR); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Health, dental, and vision benefits

Unlimited Vacation Days for Salaried F

FSA and Dependent Care Accounts

Company Paid Disability and Life Ins

Global mental health benefit

Generous 401k program

Paid sabbatical program

Job summary

4G Clinical is seeking a Study Project Lead to oversee client support for the RTSM application after go-live. You will be the expert for sponsors, manage requests, lead meetings, and train users on RTSM usage.

You will collaborate with cross-functional teams, validate configurations, and drive issue resolution while documenting work in JIRA and related specs.

Qualifications

• Minimum 3 years of software application support experience in clinical trial support.
• Excellent interpersonal skills and integrity.
• Ability to work independently and as part of a team.
• Strong customer service and problem-solving mindset.

Responsibilities

• Serve as the primary contact for sponsors after go-live for Prancer RTSM application.
• Manage sponsor emails and support requests.
• Provide timely, professional responses and status updates.
• Lead client support meetings and discuss RTSM health.
• Provide training and guidance on RTSM usage.
• Liaise with Client Directors for support updates.
• Identify and solve technical problems; drive resolution with cross-functional teams.
• Configure RTSM for enhancements and fixes; perform system validation.
• Lead User Acceptance Testing with sponsors.
• Maintain documentation in specifications, support documents and JIRA.
• Manage open requests and delegate tasks; ensure quality and timeliness.
• Act as escalation point for Study Analysts, PSSs, and Client Excellence teams.
• Escalate sponsor requests to appropriate teams.
• Identify opportunities to improve study RTSM, product, or support processes.
• Provide study-specific reporting and status updates.
• Maintain a positive, results-oriented environment, promote teamwork.

Skills

Customer service

Troubleshooting

Issue management

Problem resolution

Interpersonal skills

Attention to detail

Independent work

Teamwork

Communication

Education

Bachelor's degree in RTSM support or Information Technology

Tools

JIRA

Job description

Responsibilities

The Study Project Lead will lead client support of the Randomization and Trial Supply Management (RTSM) application after clinical study go-live. The Support Project Lead is responsible for the following:

Brief Description

Preferred Location: US East or US West

Responsibilities

The Study Project Lead will lead client support of the Randomization and Trial Supply Management (RTSM) application after clinical study go-live. The Support Project Lead is responsible for the following:

• Primary contact for clinical study sponsor after study go-live as the expert in 4G Clinical’s Prancer RTSM® application, responsible for the client’s overall support experience.
• Manage sponsor emails, providing support for troubleshooting and requests.
• Provide timely and professional responses to sponsor requests; proactively provide status updates to ensure stakeholders are informed.
• Lead client support meetings to discuss study RTSM health and open requests.
• Provide training and guidance on the use of the application.
• Primary liaison with Client Directors for support, providing updates on sponsor and study health.

• Identify and solve technical problems.
• Drive problem-solving efforts to resolution, collaborating cross-functionally as needed.
• Configure the RTSM application for system enhancements and fixes.
• Perform System Validation of configuration updates.
• Lead User Acceptance Testing with the sponsor for system updates.
• Ensure proper documentation in specifications, support documents and JIRA.

• Manage client open requests and communicate status with all interested parties.
• Delegate support tasks internally to appropriate team members and ensure work is completed with accuracy, quality and in a timely manner.
• Act as escalation point for Study Analysts (SAs), Production Support Specialists (PSSs), and Client Excellence teams for configuration change, data change and user contact questions.
• Escalate sponsor requests, issues and feedback to appropriate teams.
• Identify opportunities to improve the study IRT, product, or support processes to reduce support load and improve customer experience.
• Provide study-specific reporting and status updates as needed.
• Maintain a positive, results-oriented work environment, modeling teamwork by communicating to the team in an open, balanced, and objective manner.

The position requires a minimum of 3 years of software application support experience in clinical trial support or the equivalent. The following skills are essential: customer service, troubleshooting, issue management, and problem resolution. The candidate must also have excellent interpersonal skills and integrity, superb attention to detail, motivation to work/learn independently and the ability to work well in a team environment.

The candidate must possess a bachelor's degree or experience in RTSM support or information technology.

4G Clinical is honored to be part of Fast Company's 2020 Best Workplaces for Innovators list, citing businesses and organizations that demonstrate a deep commitment to encouraging innovation at all levels. 4G Clinical came in at #8 for its dedication to building a culture that fuels innovation, curiosity, and the spirit of experimentation in all facets of the business from product development and brand to services and staffing. We were also voted one of the 2018 Best Places in Health Care & Biopharma by Great Place to Work® and FORTUNE.

4G Clinical is a global leader in randomization and trial supply management (RTSM) and supply forecasting optimization software for the life sciences industry, offering the only fully cloud-based, 100% configurable and flexible solutions utilizing natural language processing (NLP) to accelerate clinical trials. 4G Clinical is headquartered in the Boston Biotech corridor of Wellesley, MA, with offices in Europe and Asia.

For U.S.-based candidates, we offer compelling benefits to our employees, including:

• Health, dental, and vision benefits
• Unlimited Vacation Days for Salaried Full-time Employees
• FSA and Dependent Care Accounts
• Company Paid Disability and Life Insurance
• Global mental health benefit
• Generous 401k program
• Paid sabbatical program

4G Clinical is proud to be an Equal Opportunity Employer, and it is foundational to how we recruit and hire our talented team. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by applicable law.