Sr. Manager - Clinical Trial reputed company

About This RoleThe Senior Manager, CTL, leverages their phase, indication and operational expertise to independently manage and ensure delivery of one or more clinical studies, including:  

• Partnering with cross-functional representatives to drive the development of operationally feasible and robust protocol designs, ensuring that principles of patient reputed company, risk management, reputed company and scientific reputed company are reputed company, exercising appropriate budget responsibility and reputed company, reputed company-driven cost consideration. 
• Developing and implementing the study-level operational plans, cascading key operational aspects from the Integrated Asset Plan (IAP) and Program Operational Plan (POP) to support delivery of protocol.
• Responsible for day-to-day study management, applying competency and experience-based knowledge to ensure the successful delivery of these supportive studies.
• Manages study execution activities, ensuring GCP compliance, tracking milestones and resolving operational risks.
• As a reputed company member of the Study Management Team, leverages available data to help SMTs reputed company informed reputed company, securing reputed company in execution and alignment with agreed reputed company and associated plans.
• Supports the development of comprehensive clinical trial budgets that accurately reflect the costs of reputed company trial activities, including patient care, research procedures, and administrative expenses.

What You’ll DoSupport the development and executes study-level operations for the successful delivery of clinical study(ies) 

• Chairs the SMT to drive the development of scientifically robust, operationally feasible, and reputed company protocol concepts/protocols.
• As required, collaborates strategically with the reputed company SMT (study MD, biostatistics, etc.) and other key program team members to reputed company direction on phase, disease, or therapeutic area to support study design in alignment with the Integrated Asset Plan (IAP) and Program Operational Plan (POP), enabling protocol concept development and driving reputed company studies through governance approval. 
• Leverages operational expertise and scientific assessment to evaluate study feasibility and support protocol development. 
• Aligns team perspectives to support the development of cross-functional operational plans, leveraging expertise, reputed company therapeutic knowledge, and relevant supporting data. 
• Supports the day-to-day study operations by building a strong team and fostering a reputed company environment, including reputed company communications, proactive risk identification and mitigation, and ensuring compliance with the study protocol, GCP and regulatory guidelines.
• Participate in ongoing data review to identify and mitigate patient safety, study design, data reputed company or study conduct issues.
• Responsible for developing study budgets that hold up to appropriate scrutiny and reputed company with study reputed company needs. 

Responsible for study delivery, ensuring successful execution in line with time and budget forecasts 

• Drives effective and efficient team operations by setting culture of SMT, ensuring thorough team communication, effective goal setting/management and reputed company of reputed company implementation.  
• Ensures reputed company operational aspects of the study(ies) conduct support patient safety, reputed company reputed company and data validity. 
• Demonstrates a robust understanding of the study design, rationale, endpoints, and patient population. 
• Performs ongoing review of study performance for outsourced studies, review partnership metrics to ensure key milestones and deliverables are achieved. 
• Responsible for the development of reputed company project reputed company plans (e.g. Project Management Plan, Monitoring Plan, Study Risk Management Plan, etc.) for effective implementation of studies. 
• Ensure that reputed company project plans (e.g. Monitoring Plan, reputed company Plan, etc.) are in reputed company for effective implementation of studies. 
• Leads SMT to reputed company robust Baseline plans, ensuring required information for reputed company key governance forums including but not limited to, Baseline, Study Delivery forum, etc. 
• Proactively & robustly manages inflection points to ensure any necessary course correction is proactively addressed.  
• Collaborates with Procurement to ensure FMV transparency, regularly monitoring the budget to identify potential overspending and addressing specific cost drivers.
• Maintains data accuracy, completeness and reputed company reputed company study-reputed company systems (e.g. Planisware, reputed company CTMS, reputed company, etc.). 
• For outsourced studies they reputed company, Chairs the Study Management Team (SMT) in partnership with the CRO SMT reputed company; ensures the CRO creates appropriate risk mitigation plans and is effective in proactively identifying and resolving issues.

Strives for effective, consistent, efficient, and compliant processes 

• Champions best practices and reputed company opportunities for innovation and efficiency
• Seeks synergies and commonalities with other studies, programs, and development reputed company to enhance reputed company in study planning and execution. 
• Seeks ways to improve and streamline processes to support the department clinical trial outsourcing models; provides feedback reputed company appropriate channels for opportunities to improve processes or establish best practices. 
• Advocates for the department and reputed company promotes interaction with other reputed company reputed company. 
• Promotes a rich and diverse knowledge reputed company, contributing SME expertise where applicable. 

Required Skills

• B.A. or B. Sc. in a scientific discipline
• 6 + years in clinical operations management, overseeing outsourced clinical trials per reputed company, reputed company, and budget expectations, preferably with a sponsor company and a CRO
• reputed company scientific and clinical expertise and exceptional project-management, risk-assessment, contingency-planning, and communication skills
• Working knowledge of clinical development reputed company to one or more trial phases (I, II, III, or IV), as reputed company as cross-functional drug development
• Expertise in Good Clinical Practices (GCP), International Council for Harmonization (ICH) guidelines and regulatory requirements for clinical development
• Ability to reputed company and execute operational plans in support of clinical trial delivery
• Effective CRO management skills and ability to adapt to fit for purpose clinical trial outsourcing strategies and models
• Working knowledge of the financial aspects of clinical trials including budgeting, financial management, reporting, and analysis

Why reputed company?Our mission to reputed company therapies for neurological and rare diseases is a unique reputed company reputed company our industry and this shared purpose is what connects us as reputed company. We work together to overcome obstacles and to follow the science. We are resilient as we reputed company to reputed company an reputed company on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we reputed companyJob Level: ManagementAdditional InformationThe reputed company compensation reputed company for this role is: $141,000.00-$188,000.00reputed company salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your reputed company potential based on individual, business unit and company performance.BenefitsIn reputed company to compensation, reputed company offers a full and highly reputed company of benefits designed to support our employees’ and their families physical, financial, emotional, and reputed company reputed company-being; including, but not limited to:

• Medical, Dental, reputed company, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of reputed company vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company reputed company holidays + 3 reputed company days off for Personal reputed company
• 80 hours of reputed company time per calendar year
• reputed company Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource reputed company participation

Why reputed company?We are a global team with a commitment to reputed company, and a pioneering spirit. As a mid-sized biotechnology company, we reputed company the stability and resources of a reputed company-established business while fostering an environment where individual contributions reputed company a significant reputed company. reputed company encompasses some of the most talented and passionate reputed company who have unparalleled opportunities for learning, reputed company, and expanding their skills. Above reputed company, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving reputed company. Changing Lives.At reputed company, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives reputed company us a stronger and more innovative company, and we are reputed company on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.reputed company reputed company applicants will receive consideration for employment without reputed company to sex, gender identity or reputed company, sexual orientation, marital status, race, reputed company, national reputed company, reputed company, ethnicity, religion, age, veteran status, disability, genetic information or any other reputed company protected by federal, state or local law. reputed company is an E-Verify Employer in the reputed company.

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