Director, Clinical Study Start-Up

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the formulation of pricing strategies for site budgets to facilitate contract execution and site activation.

• Partner with legal, finance, CRO, and clinical teams to guarantee that site agreements adhere to both regulatory and company standards.

• Negotiate and finalize site agreements, encompassing budgets, contracts, and necessary documentation.

• Evaluate budgets to attain the most favorable pricing.

• Present budget proposals to the Chief Accounting Officer for their approval.

• Provide comprehensive site payment estimates and forecasts in collaboration with Clinical Finance.

• Collaborate with legal counsel regarding indemnification, liability, and confidentiality clauses.

• Offer management updates on progress and trial agreement KPIs.

• Address inquiries related to budgets, invoices, payments, and purchase orders with Finance and Clinical Leadership.

• Work alongside external FSP providers on budget templates, work orders, purchase orders, and site payment procedures.

• Cultivate relationships with CROs, FSP providers, and clinical sites.

• Supervise FSP providers’ timelines, quality benchmarks, and contractual commitments.

• Identify and establish departmental processes and standards.

• Assist senior management with special projects.

• Devise and sustain outsourcing strategies for clinical trials across various phases.

• Deliver prompt, cost-efficient solutions within project timelines and budgets.

• Resolve issues and disputes related to site agreements.

• Collaborate closely with Legal, Clinical Operations, and Clinical Development teams.

• Develop and implement improvements for operational efficiency.

• Execute other assigned responsibilities.

⛳️ Requirements

• A Bachelor’s degree in Life Sciences, Business Administration, or a related field is required.

• At least 10 years of experience with clinical trial site agreements in a biotech or pharmaceutical environment.

• Experience in oncology is highly preferred.

• Exceptional global negotiation and contract management capabilities.

• Background in clinical finance, business development, or clinical operations.

• Strong financial understanding with the ability to comprehend and formulate budgets.

• Experience managing site budgets on a global level, including potential internal escalation pathways.

• Comprehensive knowledge of grant planning.

• Expertise in large, multi-site clinical trials involving various vendor types is essential.

• The ideal candidate will have experience working within departments with established processes.

• Direct experience in vetting and negotiating with sites and vendors is mandatory.

• A solid understanding of the clinical process is crucial.

• Proficient in standard MS Office applications (e.g., Word, Excel); familiarity with electronic document management systems and document review tools is advantageous.

• Strong computer and database skills are necessary.

• High attention to detail, accuracy, and confidentiality.

• Clear and effective oral and written communication abilities.

• Excellent communication, interpersonal, and organizational skills.

• Strong critical thinking and problem-solving skills with the capacity to work independently.

• Ability to prioritize conflicting demands and manage time-sensitive, highly confidential documents effectively.

• Communicate complex ideas clearly and understandably.

• Thrive in a fast-paced, demanding, and collaborative work environment.

• Knowledge of GCP guidelines and relevant regulatory requirements is essential.

🏝️ Benefits

• Bonus, stock options, benefits, and/or other applicable variable compensation may be included in the overall compensation package.

• Equal Opportunity Employer.