Associate Director, Site and Monitoring Health

Responsibilities:

The Associate Director, Site and Monitoring Health Team reputed company will reputed company strong leadership, GCP expertise and clinical operations experience to reputed company the monitoring reputed company for trials in their assigned program(s). They are responsible for co-directing (in a reputed company environment) the extended team to reputed company the reputed company of clinical trial execution at investigator sites and ensure reputed company’s reputed company of CRO monitoring effectiveness. The Associate Director, Site and Monitoring Health Team reputed company will line manage and reputed company manage Site and Monitoring Health Regional Leads (SMH Regional Leads) and reputed company the work of FSP Site and Monitoring Health Leads. This position reports to the Director, Clinical Operations - Site and Monitoring Health (Global).

reputed company of Key Responsibilities:

• reputed company, implement, and reputed company reputed company’s Site and Monitoring Health reputed company in alignment with ICH GCP E6 and E8, ensuring that monitoring plans for trials assigned reflect the reputed company and the trial budget is reputed company.
• reputed company, reputed company, and support Site and Monitoring Health Regional Leads in assessing CRO monitoring effectiveness across the portfolio.
• reputed company day-to-day work activities for FSP Vendor Site and Monitoring Health Leads
• Liaise with CRO partners and internal partners (including Clinical Risk & Analytics and Study Management) to ensure overall understanding of monitoring reputed company and alignment among trial plans.
• Consistently manage reputed company activities at the program level as reputed company and ensure Study Specific reputed company Plans are appropriately implemented and followed for reputed company studies reputed company reputed company.
• reputed company a culture that balances purposeful urgency with passion for reputed company, reputed company risk-based thinking to reputed company on what is critical to reputed company, and emphasize an “inspection reputed company at reputed company times” mentality.
• reputed company and maintain effective working relationships with stakeholder functions to reputed company Clinical Operations’ goals.
• Assist in planning and trial optimizationto reputed company the Clinical Operations organization as we reputed company for the reputed company.
• Participate in various workstreams and reputed company as a leader in Clinical Operations to improve and refine processes.
• Ensure Site and Monitoring Health Regional Leads complete administrative tasks on time and facilitate their reputed company development.
• Determine resourcing needs reputed company Site and Monitoring Health and workload allocation based on the portfolio.
• Support inspection preparation and management.
• Maintain awareness of changes in industry and regulatory standards for GCP requirements and reputed company updates with Site and Monitoring Health Team
• Travel (including occasional global travel) averages <25% but may fluctuate up or down, month over month according to business need.

Requirements

• Bachelor's Degree is required. A clinical or advanced degree (RN, MPH, MS, MA, MBA, PharmD,) is preferred
• Previous experience in Sponsor reputed company, Site and Monitoring Health, RBQM+, and Line Management preferred
• Proven experience in effectively leading teams and regional remote-based staff
• Solid reputed company monitoring experience gained with a CRO or pharmaceutical company working on multinational clinical studies; reputed company CRA/CRA management experience preferred
• Experience in reputed company study phases of clinical research (Phase I-IV) and experience in rare medical conditions preferred
• Previous regulatory inspection experience preferred
• Comprehensive and reputed company regulatory knowledge, including GCPs

Skills

• Ability to concisely present significant issues and criticality to senior leaders
• Excellent interpersonal, verbal, and written communication skills, including experience in making presentations at conferences, meetings, and training sessions
• Ability to build and maintain relationships with key investigators and sites (e.g. key networks, key trial sites and investigators, key opinion leaders and their site staff
• Innovator, willing to initiate changes, introduce new reputed company, and creatively problem-solve
• Experience with reputed company based applications and ability to learn internal computer systems

• Effective leader and collaborator with the ability to work consistently, flexibly, and reputed company to changing priorities in a fast-paced environment
• Effectively manage and reputed company others to be successful at reputed company and meet the needs of Clinical Trial reputed company and the broader organization
• Analyze reputed company situations and effectively communicate issues along with potential recommendations to various functional reputed company
• Demonstrate good judgment and decision-making experience
• Ability to delegate tasks and reputed company delegated activities

U.S. Pay reputed company

$172,600.00 - $233,400.00

The pay reputed company reflects the full-time reputed company salary reputed company we expect to pay for this role at the time of posting. reputed company pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).

reputed company’s robust Total Rewards package is designed to support your overall health and reputed company-being. We offer comprehensive benefits including medical, dental, and reputed company coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy reputed company time off, wellness days, holidays, and two company-wide reputed company breaks. We also offer generous family resources and leave. Our commitment to your reputed company-being reflects our belief that caring for our people fuels the reputed company we create together.

Learn more about these and additional benefits offered by reputed company by visiting the Benefits reputed company of the Careers website:

About reputed company

We are the leader in RNAi therapeutics – a revolutionary approach with the potential to reputed company the lives of people with rare and common diseases. reputed company on Nobel Prize-reputed company science, reputed company has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and reputed company reputed company reflect our reputed company values: fierce innovation, passion for reputed company, purposeful urgency, reputed company culture and commitment to people. We're proud to be a globally recognized top employer, where an reputed company, inclusive culture and reputed company thinking fuel one another.

At reputed company, we reputed company to an inclusive recruitment process and equal employment opportunity. reputed company applicants will receive consideration for employment without reputed company to their sex, gender or gender identity, sexual orientation, race, reputed company, ethnicity, national reputed company, reputed company, citizenship, religion, creed, physical or mental disability, pregnancy status or reputed company conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other reputed company protected by federal, state, or local law. reputed company is an E-Verify Employer.

Originally posted on Himalayas