Role Description Labcorp is seeking a remote Study Design Lead to join our Central Labs Services team. - Accurately interpret and translate sponsor protocol requirements into the protocol specific database to generate a Statement of Work for the CLS project. - Leverage technical, therapeutic area, client, and company specific process knowledge to provide a comprehensive and complete database design. - Interact with external clients regularly through all duties and responsibilities. - Liaise with internal departments to understand full company capabilities and assess feasibility of requests to meet client needs related to study design. - Act as a consultant to advise on study design choices and work with the Global Study Manager (GSM) to highlight risks and budget impacts associated with study design. - Expand consultancy capability at study program levels. - Display strong interpersonal and communication skills that will build strong internal and external relationships to ensure high quality study design. - Coordinate internal processes and communications related to study design (including but not limited to internal feasibility requests, material transfer agreements and supply forecasting) and ensure the eventual follow up is integrated into the database and global monitoring plan. - Perform quality self-review. - Ensure that all customer requirements with relation to study design are documented and acted upon. - Act efficiently in an environment with dynamic timelines and priorities. - Display appropriate self-organization and ability to manage conflicting priorities. - Participate in functional meetings (e.g. Continuous Learning Forums (CLFs)) and provide input, keeping processes up to date. - Comply with our internal Central Lab Global Project Management strategy. - Manage a portfolio of global and local studies with varying complexities. - Support a culture of continuous improvement, quality, and productivity. Qualifications - High School Diploma - 6 or more years of experience working in the clinical research industry or within a lab environment Requirements - Bachelor’s degree in a life science (preferred) - Experience working directly with internal or external customers - Strong relationship building and management skills - Familiarity with clinical or preclinical research protocols - Strong planning, organizational, and problem-solving skills - Excellent verbal and written communication skills Benefits - Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. - Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. Company Description At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Central Laboratory Services is part of a global contract research organization within Labcorp. We offer the world’s largest network of central laboratories and support global clinical trials testing. A common set of processes, procedures, and instrumentation is offered throughout our sites in Europe, Asia/Pacific, and the United States, allowing us to receive samples globally and provide more than 700 assays across all laboratory science disciplines.

Role Description As a Clinical Research Associate at ICON, you will contribute to our clinical trial operations function, working collaboratively to deliver high-quality outcomes across our clinical programmes. Your role will involve delivering clinical trial monitoring work to a high standard, working closely with your team and stakeholders. - Working independently and actively to coordinate all activities for setting up and monitoring a study, completing accurate study status reports and maintaining study documentation. - Running sponsor generated queries efficiently and taking responsibility for study cost efficiency; participating in the preparation and review of study documentation and feasibility studies for new proposals as required. - Developing and maintaining strong, collaborative relationships with key stakeholders, clinical investigators, and site staff. - Ensuring patient safety by ensuring compliance with ICON's procedures, protocols, and regulatory requirements. Qualifications - University degree in medicine, science, or equivalent. - Knowledge of ICH-GCP guidelines and the expertise to review and evaluate medical data. - Excellent written and verbal communication in English. - Good social skills enabling you to deal with queries in a timely manner. - Willingness to travel as required (approximately 60%). Benefits - Various annual leave entitlements. - A range of health insurance offerings to suit you and your family’s needs. - Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. - Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being. - Life assurance. - Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Company Description ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

Role Description The Clinical Study Team Associate (CSTA) is an essential part of the Core Study Team and is responsible for supporting key clinical trial tasks for assigned studies to ensure compliance with ICH-GCP, SOPs, and regulatory regulations. The role collaborates with global study team members and is responsible for multiple tasks that span from study start-up to study close-out, which enables the efficient execution of clinical trials to high quality standards. Organizational Relationships: - Reports to Parexel-assigned Line Management with day-to-day direction from Client. - Partners with the Clinical Study Team Lead (CSTL) in providing study level operational leadership and support to clinical study teams. - Collaborates with global cross functional study team members of varying levels of seniority to ensure completion of tasks. Primary Responsibilities: - Provides study level operational support to the Core Study Team from study start up to closeout and submission with general direction: - Management and oversight of Study Team shared spaces. - TMF maintenance, compliance, and oversight (analyze, interpret, and follow up on metrics). - Management and oversight of Study Management Platform (analyze, interpret, and follow up on metrics). - Registry and/or Clinical Trial Management system(s) compliance and maintenance. - Tracking and oversight of study level information; follow up with functional lines as needed. - Liaising with cross functional study team members: - Initiate and coordinate the completion of study level forms and data entry into various clinical operations applications and systems. - Provide study level reporting to support management of clinical trial data, clinical trial budget and timelines. - Quality Control (QC) of essential clinical trial, Clinical Study Report (CSR) and regulatory submission documentation. - Manages engagement of Independent Oversight Committees. - Provides support to the CSTL and Clinical Quality Lead with Inspection Readiness Activities. - Assists the CSTL with oversight and tracking of Clinical Trial Budget spend. - Provides logistical/operational support to Study Management for Investigator Meetings. - Provides status updates on key tasks and activities to the CSTL and contributes to the Core Study Team Meetings as an active Core Study Team member. - Works proactively with minimal oversight to coordinate and prioritize multiple key study tasks in support of clinical trial systems and processes. - Uses established procedures and methodologies to ensure the completion of assigned tasks according to timelines and to required quality standards. - On occasion, supports short term Clinical Operations Special Project requests (e.g. workstreams, initiatives, projects). - Manages conflicting priorities to ensure excellent support to assigned study teams with general direction. - Manages own time to meet agreed targets; develops plans for short-term work activities on own projects (timelines, work plans, deliverables). - Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, system, and process related training. - Adheres to EP and Client SOPs and processes. Qualifications - Bachelor’s Degree (B.S or B.A) with 1 to 3 years’ experience in pharma or CRO or Master’s Degree (M.S, M.A or M.B.A). Requirements - Proficient in Microsoft office applications (Outlook, Word, PowerPoint, Excel, TEAMS). - Relevant clinical research or clinical trial experience or relevant coursework in drug development or clinical research. Preferred Qualifications - Science background. - Experienced with clinical trial applications. - Effective verbal and written communication skills. - Ability to work independently but also as part of a larger team with limited support from supervisor. - Ability to multitask and manage multiple competing priorities. - Has fundamental knowledge of the principles and concepts related to the CSTA role. - Self-motivated and ability to organize tasks to ensure timelines are met and deliverables are of high quality. - Knowledge of drug development process. - Attention to detail evident in a disciplined approach to document review, adherence to SOPs, metrics, etc. - Good problem solving & decision-making skills. - Proficiency in written and spoken English.

Role Description The Clinical Pharmacist Utilization Management serves a critical role across utilization management, quality improvement, and regulatory compliance for Medicare Advantage and commercial pharmacy benefits. This position is responsible for making accurate, evidence-based coverage determinations and appeal decisions, supporting pharmacy quality initiatives tied to CMS Star Ratings, and ensuring compliance with CMS regulations. The pharmacist functions in a highly cross-functional capacity, partnering with operations, quality, compliance, vendors, providers, and customer service teams to improve medication access, safety, adherence, and member experience across all lines of business. Essential Duties and Responsibilities - Perform Part B and Part D coverage determinations and appeals in accordance with CMS regulations, plan benefits, and evidence-based clinical guidelines. - Conduct clinical drug utilization reviews and appropriately apply formularies and preferred drug lists. - Manage pharmacy quality programs impacting CMS Star Ratings, medication adherence, and Medication Therapy Management (MTM). - Provide medication therapy management (MTM) services, including outreach to members, providers, and pharmacies. - Support CMS audits, regulatory reporting, grievances, and PBM formulary compliance activities. - Manage pharmacy quality vendors, including MTM and medication adherence programs. - Assist in the preparation of materials or activities related to the Pharmacy and Therapeutics (P&T) and Utilization Management subcommittee. - Conduct telephonic member outreach to answer member questions, resolve member issues and close care gaps. - Complete interventions to improve biosimilar conversions across all lines of business. Qualifications - Pharm.D. or RPh from an accredited School of Pharmacy. - Active, unrestricted pharmacist license in California. - Medicare Advantage Part B and Part D utilization management experience preferred. - Strong analytical, organizational, and written/verbal communication skills. Requirements - Full-time (Exempt) - Regular position Benefits - Salary Range: $129,000 – $169,000 per year. Actual compensation varies by location, experience, education, and skill level. Company Description Equal Opportunity Employer