Advisor, Operations

Job Description

Plans, manages, and coordinates the execution of clinical study/studies according to regulatory requirements. Provides updates and ensures coordination between cross functional study team(s) to meet study objectives, on time and within budget. Provides guidance and mentors Program managers and handles additional sites.

Job Responsibility

• Provides strategic advice and guidance to the Operations function. Guides and trains Program Managers in the performance of operational duties ; provides guidance to Program Managers to improve effectiveness and achieve operational goals.
• Handles additional sites and acts as a resource for difficult or complex studies/ analysis ; gathers various metrics, analysis and reports findings to management within timeframes.
• Designs, develops and modifies systems and procedures to enhance departmental processing.
• Participates in cross functional study team(s) in protocol development, process development, data management amendments and administrative changes.
• Participates in creation and maintenance of business development activities and standard operating procedures and provides support during audits.
• Manages strategic partners, vendors, consultants for assigned studies.
• Performs the evaluation and selection of vendors, including contract and budget negotiations.
• Responsible for the day-to-day management of vendors, ensuring assignments, timeframes and budgets are met.
• Assists with site identification and selection, enrollment models, clinical supply planning and drug supply, organization of investigator and vendor meetings, development of informed consents forms, planning and management of monitoring plans and Case Report forms and writing the Clinical Study Report.
• Identifies study risks, develop risk mitigation plans, including communication and collaboration with program management, and escalates risks and study issues, with proposed solutions, to management as necessary.
• Performs related duties as required. All responsibilities noted here are considered essential functions of the job under the Americans with Disabilities Act. Duties not mentioned here, but considered related are not essential functions.

Job Qualification

• Bachelor's Degree required, or equivalent combination of education and related experience.
• 10+ years of relevant experience and 2+ years of leadership / management experience, required.

Research Intelligence Specific

We are seeking a highly organized and proactive Advisor to support Research Intelligence leadership. This role will be responsible for managing complex calendars, coordinating schedules, and ensuring smooth communication across all levels of the organization. Additionally, the role will involve project management responsibilities, ensuring the timely completion of projects, tasks, and initiatives. The ideal candidate will be a skilled multitasker with strong communication, organizational, and project management abilities

Key Responsibilities:

1. Communication Project Management:
   
   
   
   1. Draft and edit emails, letters, and reports as needed.
   2. Prepare and distribute newsletters, memos and other internal announcements.
   3. Liaison with external departments to ensure that departments and interested parties are kept apprised of activities.
   4. Manage department shared inbox.
   5. Coordinate internal communications including departmental policies and guidance.
   6. Maintain and update internal communication materials, including SharePoint content.
   
   
2. Calendar Management:
   
   
   
   1. Manage and optimize the calendars of leadership, including scheduling meetings and appointments.
   2. Coordinate internal and external meetings, ensuring appropriate timing and preparation.
   
   
3. Meeting Preparation and Follow-up:
   
   
   
   1. Prepare agendas, materials, and presentations for meetings.
   2. Take meeting minutes and ensure follow-up actions are tracked and completed in a timely manner.
   3. Ensure leadership is well-prepared for all meetings, conferences, and events.
   
   
4. Project Execution Management:
   
   
   
   1. Assist with the development and documentation of project plans, including project scope, goals, and deliverables, under the guidance of leadership.
   2. Develop and maintain standard operating procedures.
   3. Prepare reports for leadership on project progress toward milestones and deliverables.
   
   
5. Other Administrative Support:
   
   
   
   1. Perform general administrative duties as needed.
   2. Assist in organizing company events and conferences.
   
   

Other Qualifications:

• Exceptional organizational skills and attention to detail.
• Excellent communication skills, both written and verbal.
• Ability to maintain a high level of professionalism and confidentiality.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and project management software (e.g., Monday.com, Asana, or similar).
• Ability to adapt to a fast-paced environment and manage changing priorities.
• A proactive problem-solver with strong critical thinking skills.

*Additional Salary Detail
The salary range and/or hourly rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job advertisement and may be modified in the future.When determining a team member's base salary and/or rate, several factors may be considered as applicable (e.g., location, specialty, service line, years of relevant experience, education, credentials, negotiated contracts, budget and internal equity).