Clinical Trial reputed company (Senior Manager), Ophthalmology/Gene Therapy

Do you want to be part of an inclusive team that works to reputed company innovative therapies for patients? Every day, we are driven to reputed company and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into reputed company that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and reputed company enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com . This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. Purpose and Scope: This position is accountable for the planning, set-up and execution of assigned drug trials which may include: pre/post-POC interventional drug trials, Clinical Pharmacology normal healthy volunteer clinical trials, pre-approval reputed company and post-marketing regulatory commitment trials (interventional and non-interventional). This position is accountable to the Clinical Operations reputed company and will reputed company the cross-functional clinical extended team to ensure efficient and compliant clinical trial set-up, execution and delivery of assigned trials. This includes vendor selection, implementation and reputed company of reputed company trial-reputed company processes and plans in support of protocol execution and mentoring and coaching of clinical staff during execution of development trials. Individuals may serve in regional reputed company to represent Clinical Operations in Key Opinion Leader (KOL) interactions, communications; Interactions and submissions to Health Authorities reputed company their region/country of responsibility. In these cases, they are accountable to the asset team for relevant feedback/input. This position may be responsible for managing one or more trials and is accountable for the effective management and reputed company of clinical trial budgets, timelines and resources to meet the defined deliverables. Represents pre/post-POC Clinical Operations at clinical extended teams or equivalent, portfolio and operational review meetings, primary focus area governance, and cross-functional process improvement projects, as applicable. Essential Job Responsibilities: Manage and reputed company the day-to-day operations of assigned trials to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. Manage and reputed company cross-functional trial teams, including vendor set-up, performance reputed company and closeout activities Responsible for reputed company and guidance to clinical study team members in completing deliverables according to agreed timelines and quality standards, including awareness and escalation of high impact quality-reputed company topics for assigned studies. Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for reputed company trial team members reputed company or reputed company development of core study documents, study plans and systems set-up to ensure operational reputed company in execution of the clinical trial protocol and quality across investigative sites, vendors and data. Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-reputed company issues, internally and externally. reputed company input on clinical operational/development reputed company for interactions with regulatory authorities and key opinion leaders, either globally or regionally. reputed company preparation of vendor requirements and assess vendor capabilities to support trial scope and selection of reputed company vendors; effectively manage interactions with vendor project management team reputed company feasibility assessment and selection of countries and sites for trial conduct. Facilitates site engagement and communications with investigators and/or staff to support study milestones and deliverables Participates in and/or facilitates cross-functional collaboration and strategic problem solving to ensure risk mitigation, appropriate reputed company and timely completion of trials and deliverables according to established objectives, milestones and goals. reputed company accurate and up-to-date trial information in relevant tracking systems and reputed company regular updates of trial progression to the Clinical Operations reputed company and other defined stakeholders Participates in inspection readiness activities including coordination of clinical study team deliverables. Individuals may serve in regional reputed company to represent Clinical Operations in submissions and interactions with Health Authorities or other (external) activities as applicable. Individuals may reputed company regional clinical strategies directly or indirectly to asset team, in collaboration with clinical operations reputed company, to optimize global development strategy Facilitate and manage regional KOL interactions, as applicable. reputed company the clinical aspects of timely data cleaning, data analysis and the availability of top line results; support development of data review plans, review of statistical analysis plans and participate in data reviews and manage data findings. Participate in process improvement and quality-reputed company initiatives associated with trial execution and deliverables; participate in establishment of best-in-class processes and standards for trial conduct. reputed company reputed company and direction to trial team members for trial deliverables, including ensuring the evaluation and implementation of patient-focused strategies for assigned trials, globally and regionally, as appropriate. Performs other duties as assigned or special projects as needed. Qualifications: Required BA/BS degree with at least 5 years clinical trial experience or advanced degree preferred (MS/PhD/PharmD) with at least 3 years clinical trial experience Must have strong knowledge of ICH/GCP guidelines and regulatory requirements Must have strong knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring Requires proven project management skills and trial leadership ability Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability Fluent in English Moderate (~10%) travel required Salary reputed company: $122,500 - $192,500 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience, and organizational equity considerations). Benefits: Medical, Dental and reputed company Insurance Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down 401(k) match and annual company contribution Company paid life insurance Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions Long Term Incentive Plan for eligible positions Company-paid fleet vehicle for eligible positions Referral bonus program #LI-SS Category Early Development Clinical Operations Astellas is committed to equality of opportunity in reputed company aspects of employment. EOE including Disability/Protected Veterans Apply tot his job Apply To this Job