Study Start-up Strategist - REMOTE

Orbis Clinical is seeking a talented, experienced, and highly motivated Study Start-up Strategist (SSUS) in Clinical Operations with a passion for new cancer therapy development. It is a remote-based role for 12 months.

This role will be responsible for driving the start-up activities with our sites and vendors across multiple studies, thus supporting the Clinical Operations and cross-functional team in the operational execution of one or more clinical trials in start-up for early-stage clinical programs.

As a SSUS, you will be the start-up expert, responsible for mapping out the specific requirements, documents and start-up processes from our sites and our vendors across multiple studies. You will be looking for opportunities to streamline and synergize their documents and requirements with processes, and accelerate vendor and site activation across our trials while maintaining quality and adhering to internal processes. In this capacity you will be responsible for overseeing and driving study start-up activities in close collaboration with the Clinical Operations team and Contract Research Organizations (CROs) start-up team, ensuring study start-up and site activations as per agreed timelines.

What you’ll do:

• Drive site and vendor activation timelines for assigned trials, in collaboration with the Study Management Team (SMT) Lead, other internal stakeholders and vendors (including central IRBs, if applicable).
• Create Start-Up Plan for assigned studies and standardize across studies where possible.
• Develop a clear understanding of the SSU process at each study site (CDA, SSU team, protocol review, other site committee reviews, budget and contract, IRB). Partner with SMT lead on site activation projections and manage SSU timeline.
• Communicate directly with sites, CROs, and vendors to obtain updated information to assist with driving start-up activities.
• Oversee timely delivery of key start-up goals and milestones. Analyze risks and provide mitigation strategies to the SMT.
• Maintain tracking of clinical trial start-up and site activation progress including status update reports.
• Drive Confidentiality (CDA) and Site agreements (CTAs) execution strategy including review and prioritization in collaboration with legal and CRO.
• Be the counterpart for CROs SSU related to site budget negotiation framework; timely review and approval of budgets.
• Responsible for management and escalations of significant variations to site budgets; manage CRO site budget escalations.
• Ensure timely review and approval of site start-up documents, eg, Informed Consent Forms.
• Escalate trial start-up issues as appropriate to the SMT Lead.
• Establish and maintain strong relationships with internal cross-functional teams, CROs and vendors, and clinical research site personnel for successful start-up of clinical trials.
• Assist Clinical Operations team in the filing and archiving of essential documents in the TMF .
• May be assigned other projects and duties as required.

Requirements:

• Bachelor’s Degree in life science or equivalent combination of education, training, and relevant experience
• Minimum 6 years of relevant experience in biotech or pharmaceutical industry, of which a minimum of 4 years of relevant global study start-up experience from biotechnology-/pharmaceutical-, CRO- or healthcare industry
• Site contract or budget drafting, negotiation, and execution across Phase I-III clinical trials experience
• At least 1 year of vendor management experience in oncology studies
• Experience in Clinical Operations and a thorough understanding of GCP, relevant ICH standards, and FDA/EMA guidelines would be beneficial
• Good understanding of the operational structure within CRO
• Self-motivated, with initiative and able to take ownership of, and follow through with, specific tasks
• Results-oriented team player; enjoy working collaboratively with colleagues and building positive relationships
• Ability to exercise good judgment and make decision that is appropriate for the company
• Ability to demonstrate flexibility and embrace change in a dynamic, rapidly growing environment
• Analyze and triage problems, prioritize accordingly, and propose solutions
• Strive for continuous improvement and embrace innovative ideas in daily work
• Demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint, Adobe Acrobat) and experience with SmartSheet is a plus

Compensation Details:

• Orbis Clinical provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location. 
• The Pay Range for this position is $85-$95 per hour, can vary depending on employment status.
• Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k). 

EEO and Reasonable Accommodation Statement:

Stone Harbor Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.

By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.