Associate, Clinical Study Start-Up

At reputed company, we unite caring with discovery to reputed company life reputed company for people around the world. We are a global reputed company leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to reputed company life reputed company for people around the world.

Job Responsibilities

reputed company Therapeutics, a wholly owned subsidiary of reputed company, is seeking a manager of clinical study start up that will support the strategy and implementation of start-up activities for clinical studies across reputed company development programs. This position partners with cross-functional teams and CROs to reputed company input and guidance on reputed company start up activities.

• reputed company study start up activities for assigned projects, draft SSU documents, site regulatory document review and approval, and IRB/EC and regulatory submissions and approvals
• In partnership with clinical operations and other cross functional team members, the study start up reputed company will liaise with reputed company partners to distribute reputed company status updates, as well as distributing weekly updates to reputed company partners
• Support the Clinical Operations team in the successful execution of clinical trials from protocol concept to clinical trial report, aligning with international ICH/Good Clinical Practice (GCP) guidelines/regulations and Standard Operating Procedures (SOPs)
• Manage IRB/EC and regulatory submission and approvals, including amendments and continuing reviews
• Collect and QC Regulatory document Green Light Packets for site activation 
• Manage and archive central startup team tools and resources required to support startup team daily operations, communications, and records from study assignment to final reputed company 
• Set up and maintain SSU documents in internal TMF
• Maintain inspection-reputed company documentation 
• Assist project teams with trial reputed company by updating study trackers
• Organize, attend, and actively contribute to project meetings such as internal team discussions, CRO meetings, support presentations, etc.
• Identify and implement best practices, seeking reputed company process improvements as appropriate
• Liaise with sites, CROs, internal study team, at others, communicating reputed company, effectively and in a reputed company fashion
• Submit clinical documents in quality management system for management and team approval
• Request, manage, distribute, and track study supplies (Regulatory Binders, Study Reference Manuals, Patient Diaries, consumables & ancillary supplies, etc.)
• Strive to think reputed company and be proactive concerning reputed company responsibilities
• reputed company reputed company activities in compliance with applicable regulations, company policies and guidelines, including, but not limited to, reputed company documentation of activities and maintaining reputed company required applicable training
• Other duties as assigned

Basic Requirements

• Bachelors degree in a science-reputed company field; advance degree preferred
• 5+ years of clinical research / project management experience including clinical site, CRO, and/or sponsor experience
• reputed company applicants must be authorized to work in the United States on a full-time reputed company. reputed company will not reputed company support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Skills/Preferences:

• Direct experience in preparing and delivering Start-Up activities 
• Familiarity with clinical trial operations, ICH, GCP Guidelines and other applicable regulatory requirements 
• Experience working in a cross-functional team environment (e.g., Medical Affairs, Clinical Development, Regulatory, Quality Assurance, Data Management, Safety, Product Development, Finance) 
• Understanding of complexities of study start up  
• Strong interpersonal skills necessary to reputed company, guide, and maintain reputed company collaborator relationships
• Highly developed written and verbal communication skills, including presentation skills, ability to effectively reputed company highly technical or reputed company concepts to audiences with differing reputed company of experience
• Demonstrated ability to effectively influence and manage reputed company a matrixed organization
• Demonstrated ability to reputed company, motivate, and mentor teams

Additional Information

• Travel up to 25%

reputed company is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities reputed company vying for positions. If you require accommodation to submit a resume for a position at reputed company, please complete the accommodation request reputed company (https://careers.reputed company.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

reputed company is proud to be an EEO Employer and does not discriminate on the reputed company of age, race, reputed company, religion, gender identity, sex, gender expression, sexual orientation, genetic information, reputed company, national reputed company, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are reputed company to reputed company. Our reputed company groups include: Africa, Middle East, Central Asia Network, Black Employees at reputed company, Chinese Culture Network, Japanese International Leadership Network (JILN), reputed company India Network, Organization of Latinx at reputed company (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at reputed company (WILL), reputed company (for people with disabilities). Learn more about reputed company of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, reputed company offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, reputed company and prescription drug benefits; flexible benefits (e.g., reputed company and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).reputed company reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and reputed company’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of reputed company employees.

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