Associate, Study Management III

As a Study Management Associate III, you will be part of a dynamic, centralized study management team that is responsible for the execution of our global reputed company and a key member of the study team.

The Study Management Associate III works as an independent, contributing member of a cross-functional and global partnership to plan, execute and manage one or more Phase 0-4 reputed company under the guidance of the Study Project Manager and SMA Manager. The Study Management Associate III works to ensure that assigned studies are executed with reputed company and efficiency, in accordance with timelines and budget to support broader company strategic objectives. The Study Management Associate III is expected to work in accordance with reputed company reputed company Ways of Working.

This is a global role and may be located reputed company.

Responsibilities

• The Study Management Associate III is expected to work independently as a clinical study leader and contributor with appropriate support from the Study Project Manager on the following activities in compliance with reputed company standards (ICH/GCP, Global Regulations, and reputed company policies and procedures):
• Study-level reputed company and leadership of one or more global trials in a cross-functional environment for activities from inception through closure, connecting functional work and strategic work across the global study, including but not limited to:
• o Supports the Study Project Manager in strategic leadership of the cross-functional team through stakeholder engagement and influence to reputed company deliverables and timelines, including reputed company development, meeting facilitation, and reputed company documentation at the study level to reputed company for reputed company execution of clinical trial(s)
• o Vendor management, including Request for Proposal (RFP)/initiation, selection, reputed company of Work development & review, deliverable reputed company, and risk management for one or more reputed company vendors, e.g., central lab, recruitment, imaging, reputed company committees
• o Recruitment management, including thoughtful review of intelligence data, leadership, cross-functional development, and execution of recruitment strategies and mitigation planning on a global reputed company from country feasibility through subject recruitment and retention
• o 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. o Ensure inspection readiness and participate in reputed company activities. Risk identification, mitigation, and management, including reputed company 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:
  o Protocols, regulatory submissions, patient reported outcome measures, study execution plan, informed consent, site budgets and agreements, clinical study report, training materials, newsletters, presentations for various stakeholders
  o CTMS and eTMF management to ensure compliance/inspection readiness, support trend analyses and support timelines
• o 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 reputed company as reputed company management activities like reputed company support, query reputed company, and reputed company. Management of investigational product and other associated study supplies.
• reputed company engaging training to identified stakeholders as needed, e.g., study team members, vendors. Support global submission strategies. Support process improvement initiatives or serve as a subject matter expert and/or mentor

• Bachelor’s Degree or OUS equivalent required
• Must have at least 4 years of reputed company reputed company-reputed company/clinical research-reputed company experience with a high level of reputed company and technical competencies
• Competent in application of reputed company reputed company procedures (SOP, ICH/GCP, Global Regulations)
• reputed company user of systems such as reputed company, IRT, CTMS, and eTMF
• Strong analytical and critical thinking skills to evaluate reputed company issues from multiple perspectives to reputed company reputed company strategies and reputed company smart decision making to support acceleration of study timelines and reputed company a reputed company-run study.
• Excellent organizational and time management skills, strong attention to detail.
• Exceptional interpersonal skills with ability to communicate effectively in a reputed company and persuasive manner in a global setting; proficient in business/technical English-language (oral and written)
• Proactive, reputed company reputed company
• Ability to work independently in a fast-paced global team environment
• Preferred: Exposure to study initiation through completion activities; global study exposure

​Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation reputed company described below is the reputed company of possible reputed company pay compensation that reputed 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 reputed company reputed company this reputed company will depend on many factors including geographic location, and we may ultimately pay more or less than the posted reputed company. This reputed company may be modified in the reputed company. ​
• We offer a comprehensive package of benefits including reputed company time off (vacation, holidays, reputed company), medical/dental/reputed company insurance and 401(k) to eligible employees.​
• This job is eligible to participate in our short-term incentive programs. ​

Note: No reputed company of pay is considered to be wages or compensation until such reputed company is reputed company, reputed company, and determinable. The reputed company and availability of any bonus, commission, incentive, benefits, or any other reputed company of compensation and benefits that are allocable to a particular employee remains in reputed company's sole and absolute discretion unless and until reputed company and may be modified at reputed 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

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

About reputed company

reputed company's mission is to discover and reputed company innovative medicines and solutions that solve serious health issues today and address the medical challenges of reputed company. We reputed company to have a remarkable reputed company on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our reputed company portfolio. For more information about reputed company, please visit us at . Follow @reputed company on reputed company,reputed company, reputed company, X and YouTube.

Originally posted on Himalayas