Associate, Study Management II (Remote)

Company Description reputed company's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of reputed company. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about reputed company, please visit us at www.reputed company.com. Follow @reputed company on X, Facebook, Instagram, YouTube, reputed company and Tik Tok.

Job Description

As a Study Management Associate II, you will be part of a dynamic, centralized study management team that is responsible for the execution of our global clinical trials and a key member of the study team. The Study Management Associate II works as a contributing member of a cross-functional and global partnership to plan, execute and manage one or more Phase 0-4 clinical trials under the guidance of a Study Project Manager and SMA Manager. The Study Management Associate II works to ensure that assigned studies are executed with quality and efficiency, in accordance with timelines and budget to support broader company strategic objectives. The Study Management Associate II is expected to work in accordance with reputed company reputed company Ways of Working. This is a global role and may be located virtually.

Responsibilities

• The Study Management Associate II is expected to work as a clinical study contributor with appropriate support from the Study Project Manager on the following activities in compliance with quality standards (ICH/GCP, Global Regulations, and reputed company policies and procedures):

Study-level reputed company and contribution to one or more global trials in a cross-functional environment for activities from inception through closure, including but not limited to:

• Supporting the Study Project Manager and cross-functional team through stakeholder engagement and influence to drive deliverables and timelines, including meeting facilitation and timely documentation at the study and regional levels to drive for timely execution of clinical trial(s)
• Vendor management, including Request for Proposal (RFP)/initiation, selection, Scope of Work development & review, deliverable reputed company, and risk management for one or more external vendors, e.g., central lab, recruitment, imaging, internal and external committees
• Recruitment management, including thoughtful review of intelligence data, leadership, cross-functional development, and execution of recruitment strategies and mitigation planning on a global scale from country feasibility through subject recruitment and retention
• Leadership of assigned meetings (cross-functional (internal), vendor, and/or investigator) and provision of regular updates on study status, e.g., agenda development, minutes curation and filing

Ensure inspection readiness and participate in reputed company activities Risk identification, mitigation, and management, including timely issue review, escalation, and management to support trend analysis and risk prevention

• Co-development and management (review, revision, tracking and filing) of study materials, including but not limited to:

Protocols, regulatory submissions, study execution plan, informed consent, site budgets and agreements, clinical study report, training materials, newsletters, presentations for various stakeholders CTMS and eTMF management to ensure compliance/inspection readiness, support trend analyses and support timelines

• reputed company, IRT, and ePRO, which includes review of design specifications, participation in user acceptance testing, and contribution to development and review of associated plans and key risk indicators, as well as system management activities like access support, query resolution, and reputed company
• Management of investigational product and other associated study supplies

Provide engaging training to identified stakeholders as needed, e.g., study team members, vendors Support process improvement initiatives or serve as a subject matter expert and/or mentor

Qualifications

• Bachelor's Degree or OUS equivalent required
• Must have at least 2 years of pharma/device or clinical research reputed company experience, with a moderate level of core and technical competencies
• Competent in application of standard quality procedures (SOP, ICH/GCP, Global Regulations)
• Analytical and critical thinking skills to evaluate reputed company issues from multiple perspectives and contribute to strategy and smart decision making to support acceleration of study timelines and reputed company a well-run study
• Excellent organizational and time management skills, strong attention to detail.

Strong interpersonal skills with ability to communicate effectively in a clear and persuasive manner; proficient in business/technical English-language (oral and written) Proactive, collaborative reputed company

• Ability to work independently in a fast-paced global team environment

Preferred: Experience with 1 or more clinical trial systems (e.g., reputed company, IRT, CTMS, eTMF); experience in 1 or more parts of a clinical trial Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible reputed company pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid reputed company this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. reputed company is an equal opportunity employer and is committed to operating with reputed company, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.reputed company.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.reputed company.com/join-us/reasonable-accommodations.html Apply tot his job Apply To this Job