This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description This role offers a high-impact opportunity to oversee the financial health of complex clinical trials from startup to closeout. You will ensure that budgets are accurate, revenue is recognized correctly, and payments to providers and patients are processed efficiently. Acting as both operator and advisor, you will work closely with clinical teams to align financial processes with operational goals, proactively identify risks, and support decision-making. This position provides exposure to Clinical Trial Management Systems (CTMS), revenue workflows, and multi-stakeholder environments, offering the chance to mentor colleagues, improve financial operations, and strengthen the infrastructure of a growing research network. You will be part of a collaborative, mission-driven team that values precision, accountability, and innovation in advancing therapeutic research. - Manage the full financial lifecycle of assigned clinical trials, including budget creation, revenue recognition, invoicing, cash application, and accounts receivable follow-up. - Review and interpret clinical trial budgets, contracts, and study profiles, monitoring trial financial progress and compliance. - Oversee Clinical Trial Management System (CTMS) activities, ensuring accurate scheduling, visit tracking, and system support for site staff. - Manage provider payments and patient stipends, resolving issues promptly and maintaining compliance with study protocols. - Partner with clinical teams to align financial processes with operational needs, sharing best practices and supporting audits or special projects. - Mentor and onboard new staff, providing guidance on CTMS, revenue processes, and financial operations. Qualifications - 3+ years managing clinical trials in a CTMS environment; 5+ years preferred. - Bachelor’s degree or equivalent experience in finance, accounting, business, or related field. Requirements - Strong understanding of clinical trial budgets, revenue workflows, invoicing, cash application, and accounts receivable. - Familiarity with CTMS tools and site financial support processes. - Excellent communication and collaboration skills. - Proactive problem-solving abilities. - Ability to guide and mentor others. - Strong attention to detail. - Ability to work remotely, navigate clinical/office environments as needed, and participate in occasional travel. Benefits - Competitive salary and comprehensive compensation package. - Health, dental, and vision insurance. - Paid time off and flexible scheduling. - Retirement savings plan and professional development support. - Opportunity for career growth and internal advancement. - Meaningful work contributing to patient care and medical research. - Collaborative and mission-driven team environment.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Laboratory Operations Programming Lead - REMOTE. In this pivotal role, you will lead the initiatives to streamline laboratory processes while integrating computational programming expertise. Your work will significantly enhance the efficiency and quality of data generated and samples delivered, directly impacting our commitment to improving health outcomes. You will collaborate with various teams to ensure compliance and integrity throughout clinical operations, leveraging your programming skills and operational insights. This role is essential in driving departmental goals and navigating challenges while fostering excellent stakeholder communication. - Establish and streamline SKDL processes to increase efficiency and implement analytical tools. - Support SKDL operations, ensuring integrity and completeness for database locks. - Use programming languages to clean data and comply with data guidelines. - Aggregate and extract key information from operational reports. - Perform data mapping and maintain knowledge of structured data. - Ensure compliance with informed consent forms (ICFs) and manage internal sample handling. - Review metrics related to clinical study samples and logistics. - Lead cross-functional study teams and manage vendor relationships. - Support monitoring of clinical trial biosamples from collection to disposal. - Anticipate challenges and mitigate risks in SKDL projects. - Enhance communication with senior stakeholders to align functions. Qualifications - Proficiency in programming languages (R, Python, Perl, SQL, MATLAB). - Familiarity with APIs, database development, and Linux/Unix environments. - Ability to analyze sample interdependencies and risks in clinical studies. - Strong problem-solving, project management, and organizational skills. - Extensive experience in process development and project management. - Excellent oral and written communication and presentation skills. - Advanced knowledge of Excel. - 6-7 years of experience in lab operations and programming preferred. Benefits - Opportunity to work remotely and maintain a work-life balance. - Join a mission-driven team focused on improving global health. - Engage in impactful projects that directly benefit patient outcomes. - Continuous learning and professional development opportunities. - Collaborative work environment with experienced professionals. - Competitive salary and benefits package.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description In this role, you will lead the planning, execution, and delivery of complex clinical trials, potentially spanning multiple studies. You will provide strategic and operational oversight to ensure trials are completed on time, within budget, and in compliance with regulatory and quality standards. Acting as the primary cross-functional study lead, you will coordinate teams, vendors, and investigators while driving consistent progress toward key milestones. This role offers the opportunity to influence study design, optimize operational efficiency, and enhance patient and site engagement. Success requires strong leadership, attention to detail, and the ability to manage competing priorities in a fast-paced clinical research environment. You will contribute directly to advancing innovative therapies, ensuring high-quality data and impactful outcomes. - Develop and execute study operational plans, driving trial execution strategies and vendor governance to meet study milestones. - Oversee the creation, review, and maintenance of study documents including protocols, ICFs, CRFs, CSRs, and training manuals. - Ensure compliance with GCP, ICH E6 (R3), SOPs, and regulatory requirements through monitoring, quality control, and risk management. - Manage clinical trial budgets, site agreements, accruals, and vendor invoices, maintaining accurate financial oversight. - Build and maintain strong relationships with investigators, site staff, and cross-functional teams to support study conduct and data integrity. - Provide oversight of CROs and vendors, including selection, onboarding, performance management, and issue resolution. - Lead and mentor team members, ensuring resources are aligned, goals are clear, and performance meets trial milestones. Qualifications - Bachelor’s degree in a scientific or medical field (or equivalent experience). Advanced degrees preferred. - 10–12 years of clinical operations experience in the biopharma industry. - Proven track record leading cross-functional teams to deliver clinical trials from start-up to close-out, including financial management, data review, and reporting. - Strong expertise in vendor management, eTMF, SOP development, CAPA management, and quality assurance. - In-depth knowledge of clinical trial design, protocol development, GCP, ICH E6 (R3), and GDPR; experience with rare or orphan diseases preferred. - Exceptional leadership, organizational, and multitasking skills, with excellent written and oral communication. - Experience with project management and collaboration tools (e.g., Smartsheet) is a plus. - Willingness to travel periodically to fulfill role responsibilities. Benefits - Competitive salary range: $177,700—$220,000 USD (depending on experience and location). - Annual performance bonus and company equity opportunities. - Comprehensive health, dental, vision, and wellness benefits. - Retirement savings plans with employer contributions. - Flexible work environment with remote options and support for professional growth. - Paid time off, holidays, and additional leave benefits to support work-life balance. - Opportunities for training, mentoring, and career development in a global clinical research environment.

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Job Description At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies. The PPD FSP Solution: PPD's Functional Service Provider division partner with and serve as an extension of our PPD team, supporting our customers key functions. We cover customer needs on every level, allowing them to do more with less, with an uncompromising commitment to quality. We deploy the same top-tier talent in ALL engagement models. Exceptionally trained, rigorously supported and technologically empowered to help customers manage capacity and set programs up for success. Joining within our PPD FSP functional area, allows you to join the renowned PPD CRO and still gain invaluable client dedicated experience. Summarized Purpose: Manages, selects, trains, resources, coaches and performance management of respective staff. Focuses on end results using metrics and key performance indicators to manage performance. May lead or contribute to initiatives that enhance the department's performance or lead to process improvement across the company. Collaborates with clinical operations senior management and executive staff on strategic planning and business development as required. Acts as point-of-escalation regarding performance concerns and training needs to ensure adherence to the company's SOPs and WPDs. Works in collaboration with the leadership team for resourcing needs. Essential Functions • Manages staff, providing coaching, mentorship and work direction. • Conducts regular performance appraisals and career discussions with staff. Facilitates employee career development. Interviews, recruits and selects staff. • Manages and conducts induction/orientation programs for all new employees, ensuring their smooth assimilation into the company. • Ensures all staff CVs, training records, position profiles and experience profiles are complete and up-to-date. Ensures timeliness and accuracy of timesheets and expense reports. • Supports allocation activities per the local resourcing process. Supports activities of project leads/functional leads to optimize the operational running of projects. Escalates appropriately any issues which may impact project deliverables. • Delivers training on Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs), local requirements and any other subjects that impact on clinical operations. Identifies training gaps and ensures that training requirements are met. May contribute to development of training programs, where appropriate. • Assures adherence to good ethical and regulatory standards. • Alerts management to quality issues, request QA audits as appropriate, and facilitate client and internal quality assurance audits as required. • Manages and reviews systems (e.g. Activate, CTMS, Preclarus, Clarity) to evaluate employee and project metrics, KPIs and general project status. • Evaluates work of staff, including conducting MAST visits (either remote or on-site) to thoroughly evaluate the employee monitoring skills and project conduction when applicable. • Participates in process improvement/development initiatives. • Ensures understanding and facilitation of the risk based monitoring approach. • May provide input into bids and contribute to the procurement of new business where required. Policy & Strategy Interprets and administers policies, processes, and procedures that may affect sections and subordinate work units. Requires full knowledge of own area of functional responsibility. Freedom to Act Assignments are defined in terms of activities and objectives. Work is reviewed upon completion for adequacy in meeting objectives. A portion of the time may be spent performing individual tasks. Liaison Interacts frequently with internal personnel and outside representatives at various levels. Participates and presents at meetings with internal and external representatives. Interaction typically concerns resolution of operational and scheduling issues. Education and Experience: • Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years). • 1+ year of leadership responsibility • In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. • LOCATION: US-Based, West Coast, preferred. • FSP or Client-dedicated exp. preferred. • Overall Oncology exp., preferred. • Monitoring exp., Leadership exp., functional mgmt. exp, preferred. Knowledge, Skills and Abilities: • Advanced mentoring/leadership/supervisory skills • Excellent clinical trials monitoring skills; Remote and on-site • Demonstrated understanding of or ability to learn the company’s SOPs, WPDs, and relevant regulations (e.g. ICH/GCP, FDA guidelines) • Demonstrated ability to evaluate medical research data • Strong organizational and negotiation skills • Strong attention to detail • Advanced written and oral communication skills • Good knowledge of English language and grammar • Demonstrated use of computer to include data entry, archival and retrieval • Ability to travel as needed • Excellent team player with team building skills • Excellent interpersonal and conflict resolution skills • Advanced ability to utilize problem-solving techniques applicable to constantly changing environment • Solid knowledge of medical/therapeutic areas and medical terminology Management Role: Manages experienced professionals and / or subordinate management who exercise latitude and independence in their assignments. Often heads one or more sections or a small department.