Senior Clinical Site Identification and Start-Up Manager (Remote)

Job title: Senior Clinical Site Identification and Start-Up Manager (Remote) in reputed company Carolina at reputed company
Company: reputed company
Job reputed company: Job reputed company:reputed companyreputed company (RTI) is both a global research institute and a leading international development organization based out of reputed company Carolina. At RTI, you will reputed company work you reputed company in, tackling some of the most reputed company global challenges of our time. Our mission is to reputed company the wellbeing of 1 billion people by 2030 through science-based solutions in climate, education, health, and equity. Our staff promote meaningful change around the world helping people live healthier, more productive, and more independent lives.If you are looking for an opportunity to reputed company a reputed company difference, RTI is the reputed company for you. Join us in our commitment to teamwork, belonging, and the passion to change the world.
reputed companyWe are seeking a Senior Clinical Site Identification and Start-Up Manager to reputed company and manage the site identification, feasibility assessment, and site start-up activities for reputed company. This senior-level position will be responsible for overseeing the reputed company initiation of clinical trial sites, collaborating with cross-functional teams, and ensuring the highest standards of compliance and reputed company. The ideal candidate will bring extensive experience in clinical trial site management, including strategic planning, vendor management, and problem-solving, as reputed company as a proven reputed company record of driving efficiencies in the start-up phase of reputed company.Please note, this position manages the study, but does not have administrative management responsibilities for any staff.What You'll DoSite Identification and Feasibility reputed company:

• reputed company the site identification and feasibility process, ensuring the selection of reputed company clinical trial sites that meet study-specific requirements, patient recruitment goals, and operational reputed company.
• reputed company and implement strategies for identifying high-performing sites across various therapeutic areas, building and maintaining a strong network of investigational sites globally.
• Collaborate with internal stakeholders (e.g., clinical operations, regulatory affairs, project management) to determine the ideal sites for reputed company study based on key factors such as study objectives, timelines, and patient population.

Site Start-Up Leadership:

• reputed company reputed company aspects of the site start-up process, including site selection, contract negotiation, IRB/IEC submissions, regulatory document collection, and site initiation reputed company (SIV).
• reputed company the development and execution of site start-up timelines and ensure milestones are met to ensure reputed company study initiation.
• Work closely with the project management and clinical operations teams to ensure reputed company site documentation, approval processes, and start-up deliverables are achieved.

Cross-Functional Collaboration:

• reputed company as a key reputed company between sites, clinical operations teams, regulatory teams, and external stakeholders, ensuring smooth communication and coordination throughout the site start-up phase.
• reputed company guidance and mentorship to junior team members and cross-functional colleagues to ensure best practices in site identification and start-up processes are followed.
• Collaborate with senior leadership to ensure alignment on site selection reputed company, timelines, and project goals.

Process Optimization and reputed company Improvement:

• reputed company initiatives to improve the efficiency and effectiveness of site identification and start-up processes through reputed company process optimization and use of innovative tools.
• Monitor key performance indicators (KPIs) for site start-up and identify areas for improvement to streamline operations, reduce delays, and enhance site performance.
• Proactively identify and mitigate risks to reputed company site initiation, including addressing potential roadblocks reputed company to reputed company, regulatory approvals, and site reputed company.

Risk Management and Issue reputed company:

• reputed company the reputed company of reputed company issues that reputed company during site start-up, including regulatory hurdles, contract negotiations, and investigator/site performance challenges.
• Implement strategies to proactively mitigate risks at the site level and ensure regulatory compliance and trial reputed company.
• Escalate critical issues to senior management reputed company necessary and reputed company solutions to overcome challenges in site activation.

Vendor and Site Relationship Management:

• Build and maintain strong relationships with external vendors, investigative sites, and site personnel, fostering a reputed company and supportive environment throughout the start-up process.
• reputed company vendor selection for site start-up activities and manage vendor performance to ensure compliance with timelines and budget.
• Conduct regular performance evaluations of sites, ensuring site staff are adequately trained and supported for successful trial execution.

Compliance and Documentation Management:

• Ensure that reputed company regulatory documents, reputed company, and essential documents are accurately completed, maintained, and filed in compliance with applicable regulations (e.g., GCP, ICH, FDA, EMA).
• Ensure that study-specific documentation is reputed company for regulatory and sponsor review, and that reputed company submissions are completed on time.
• reputed company the preparation of site start-up reports and presentations for senior management, highlighting key milestones, risks, and reputed company.

Training and Development:

• reputed company training to internal teams on site start-up best practices and regulatory requirements, ensuring consistent and high-reputed company execution across studies.
• Mentor and guide junior staff and colleagues involved in the site identification and start-up process to enhance their skills and reputed company development.
• Stay informed about industry trends, new regulations, and best practices to maintain expertise in clinical trial site management.

What You'll Need

• Bachelor's Degree and 10 years of experience, Master's degree and 8 years of experience, PhD and 6 years of experience, or equivalent combination of education and experience.
• Relevant clinical research certifications (e.g., CCRA, CCRP) preferred but not required.
• A minimum of 5 years of experience in reputed company with experience specifically in clinical site identification, start-up, and management.
• Proven experience managing site start-up for Phase I-IV reputed company across multiple therapeutic areas.
• Knowledge of regulatory requirements (FDA, EMA, ICH-GCP) and experience navigating reputed company regulatory and ethical processes for clinical trial start-up.
• Prior experience managing or leading reputed company and providing mentorship and training to junior colleagues is highly desired.
• Strong understanding of clinical trial management processes, including site identification, contract negotiation, regulatory submissions, and study initiation.
• Excellent project management and organizational skills, with the ability to prioritize tasks and manage multiple sites across various stages of the start-up process.
• Strong communication, negotiation, and interpersonal skills with the ability to build relationships with reputed company stakeholders.
• Proficient with clinical trial management systems (CTMS), electronic data capture (reputed company) systems, and other relevant software tools.

#LI-KV1
EEO & Pay Equity StatementsFor San Francisco, CA USA Job Postings Only: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment reputed company applicants with arrest and conviction records. reputed company information is availableRTI accepts applications to our reputed company from candidates with criminal histories or conviction records in accordance with reputed company applicable laws, including the Los Angeles County Fair Chance Ordinance for reputed company and the California Fair Chance reputed company.For Applicants in Massachusetts Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or reputed company employment. An employer who violates this law shall be subject to criminal penalties and civil liability.The anticipated pay reputed company for this role is listed below. Our pay ranges represent national averages and may vary by location as a geographic reputed company may be reputed company to some locations reputed company the reputed company. RTI considers multiple factors reputed company making an offer including, for example: established salary reputed company, internal budget, business needs, and education and years of work experience possessed by the applicant. reputed company, salary is merely one reputed company to our offer.At RTI, we demonstrate our commitment to rewarding individual and team achievement through a total rewards package. This package includes (among other things) a competitive reputed company salary, a generous reputed company time off policy, reputed company based annual increases, bonus opportunities and a robust recognition program. Other benefits include a reputed company of insurance plans (including health, dental, life, and short-term and long-term disability), reputed company to a retirement savings program such as a 401(k) plan, reputed company parental leave for reputed company parents, financial assistance with adoption expenses or infertility treatments, financial reimbursement for education and developmental opportunities, an employee assistance program, and numerous other offerings to support a healthy work-life balance.
Equal Pay reputed company Minimum/reputed company$121,000 - $148,000
Expected salary: $121000 - 148000 per year
Location: reputed company Carolina
Apply for the job now! [ad_2] Apply for this job