[Hiring] Study Start-up Lead @Rho Inc

Role Description

The Study Start Up (SSU) team provides successful end to end coordination of Study Start-Up planning and execution activities including, but not limited to, investigator assessment and identification, pre-study development, site qualification, and site activation. SSU is a pivotal role requiring collaboration with internal and external stakeholders, working closely with the clinical study team, other internal functional areas, and Sponsors to support the study start-up process.

What You’ll Be Doing:

• Project Oversight & Support:
  • Leads and manages regional SSU efforts and develops Start-Up plans for country and site activation on studies of moderate scope and complexity.
  • Participates in Sponsor meetings with respect to study start-up, including endorsement of the SSU operational targets & mitigation of delivery risks, establishing client expectations for delivery, communication, reporting, and metrics with oversight from a higher level SSU Lead when necessary.
  • Partners closely with both Functional Leads and SSU team members to proactively identify and resolve study start up related issues.
• Feasibility & Site Identification:
  • Oversees country and site feasibility activities, ensuring timely collection and evaluation of site capabilities, Regulatory & IRB/IEC considerations, and study-specific requirements; reviews / interprets site feasibility data to identify risks or barriers to site selection and activation.
  • Coordinates with internal teams to confirm site recommendations and ensure alignment with study strategy.
• Regulatory & IRB/IEC Submissions & Approvals:
  • Drives the regional Regulatory and IRB/IEC submission and approval strategy and manages country-level Regulatory and IRB/IEC submission and approval timelines.
  • Participates in and coordinates country-level Regulatory and IRB/IEC submission preparation and approval activities, ensuring compliance with regional requirements.
  • Coordinates cross-functional input (Regulatory, Medical, Legal, Clinical Operations) to prepare complete and accurate Regulatory and IRB/IEC submission packages.
• Site Essential Documents (SED) & ICF:
  • Coordinate Informed Consent Form (ICF) development, country adaptation, review, negotiation, and approval with senior SSU support as needed.
  • Manage Site Essential Document (SED) requirements, templates, collection, review, approval, and second-level quality checks.
• Budget & Contracts:
  • Drives site budgets and contract negotiations, gains approval from Sponsor and Rho Legal, and files completed documents.
  • Collaborates with applicable departments, Client, and stakeholders for obtaining site budget and contract templates and negotiation tools/trackers.
  • Provides updates to Sponsor and internal team regarding negotiation progress and anticipated timelines.
• Systems, Metrics & Handoffs:
  • Ensures that relevant SSU systems are maintained and up to date to analyze study start up progress metrics against targets/timelines.
  • Ensures accurate documentation and timely handoffs to sponsor and internal project team.
• Stakeholder Engagement & Communication:
  • Serves as the point of contact for client matters related to study start-up.
  • Partners with Clinical Team Leads, CRAs, and the client to develop a strategy and timing for the Site Initiation Visit (SIV) and Site Activation.
  • May support business development with proposal and bid defense efforts, including representing Rho in proposal meetings.
• Mentoring, Coaching, Leadership & Training:
  • Provides operational oversight, guidance, and constructive feedback to SSU Associates on assigned projects.
  • Oversees work quality of SSU Associates, providing clear expectations, timely feedback, and performance coaching.
  • Leads components of project team meetings, delegating tasks appropriately and ensuring clarity of responsibilities.

Qualifications

• Bachelor’s Degree along with at least 4 years clinical research experience, with 3 years of clinical study start up experience; global study start up experience is preferred.
• Sound understanding of applicable international and local Regulatory and IRB/IEC requirements and guidelines (i.e., ICH; GCP, and/or EU; Directives); Good knowledge of Regulatory and IRB/IEC submission processes for assigned countries.
• Strategic and creative risk management and contingency planning.
• Strong written, verbal communication, and presentation skills with the ability to express complex ideas to study personnel, internal and Sponsor team members.
• Strong organizational skills and ability to manage priorities across multiple studies and interpersonal skills.
• Strategic, tactical, and critical thinking skills with a client-focused action-oriented approach to work.
• Proficient computer and internet skills, including working knowledge of MS Office applications, such as MS Outlook, Word and Excel.

Benefits

• Rho provides a comprehensive benefits package for all benefit-eligible employees, which includes medical, vision, dental, HSA, FSA, EAP, life & disability insurance and 401(k).
• All employees are eligible for paid time off, holidays, parental leave and bereavement leave.
• Flexibility: We encourage a work-life balance that allows employees to bring their best selves to work while being passionate about their lives outside work.
• The range of starting pay for this role is $75,000 - $95,000 per year.