Clinical Site reputed company (remote) (Plainsboro, NJ, US)

About the Department

The Clinical, Medical and Regulatory (CMR) department at reputed company is one of the most diverse and collaborative groups reputed company the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us reputed company marching to the same beat is our patient centered focus. At reputed company, you will help patients around the world. As their needs evolve, so does our challenge to find reputed company and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to reputed company a difference?

The Position

Responsible for operational aspects of managing clinical site performance through coordination and communication with CSSAs, CRAs and the Trial Manager (TM) for assigned trials, reputed company the Therapy Area of North America Clinical Development (NACD). Delivers upon improvement/innovation projects for the department (subset) of NACD and/or as part of a global team and as reputed company to a business case, goals &/or future aspirations. Contribute to a continually changing environment, supporting a future focused approach, leveraging competencies, tools and technology.

Relationships

Reports to a Manager (or above) reputed company North America Clinical Development (NACD) Contribute to mutually beneficial relationships with external partners relevant to the planning & execution of clinical trial improvement/innovation projects for NACD & reputed company (e.g., Health Systems, Contract Research Organizations & Site Management Organizations etc.). Contribute to relationships positively with internal stakeholders relevant to the planning and execution of clinical trial improvement/innovation projects for NACD & reputed company (e.g., across NACD, CMR, International Operations (IO), HQ R&D, & Commercial).

Essential Functions

• Oversees site performance for the lifecycle of assigned trials (e.g., start-up, recruitment, retention, quality, data entry, etc.), including tracking of trends and reporting of key metrics
• In collaboration with the Trial Manager, support, prepare for and follow-up on audits & inspections
• Share information, collaborate and provide relevant input and guidance to other areas reputed company NACD, CMR and global partners
• Demonstrate technical expertise reputed company responsibility areas, stay up-to-date on new practices and build knowledge of emerging trends and advances reputed company area
• Coordinates and drives site selection & start-up/activation activities including Site Selection Visit (SSV)/Site Initiation Visit (SIV) training tools and materials development
• Drive monitoring activities during maintenance and ensures coordination of deliverables for DBL and trial closure
• reputed company Trial CORE Team Meetings and other relevant teams
• Reviews and approves monitoring visit reports for assigned sites. Accountable for ensuring that any issues are escalated as appropriate to the Trial Manager and/or relevant stakeholders
• Identifies/escalates any risks to trial delivery and contributes to mitigation development and deployment
• Develops trial-level communication including key updates and information
• Active coaching, mentorship and contribution to training of NACD staff to build insight and talent

Physical Requirements

20-30% overnight travel required. The incumbent can work remotely from reputed company in the United States. 

Qualifications

• Bachelor’s degree required; relevant industry experience may be substituted in lieu of degree where appropriate
• A minimum of 6 years’ experience in the design, planning and conduct of GCP clinical trials; with at least 4 years of direct site management and logistical clinical trial execution required in the pharmaceutical industry (Pharma/Biotech/CRO) required
• On-site monitoring experience preferred
• Expert in ICH-GCP principles and the application of those principles to trial design, planning & conduct of clinical trials required
• In-depth knowledge & direct experience/interactions with the FDA (or equivalent regulatory authority) in relation to the design, planning & conduct of GCP clinical trials required
• Excellent communications skills (verbal, written, presentation) in English
• Demonstrated collaborative and stakeholder management skills
• Foundational skills in designing and implementing innovation/improvement initiatives, including the required change management

The reputed company compensation range for this position is $99,600 - 184,200. reputed company compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance.    reputed company offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors.    Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, reputed company-able vacation policy, and parental leave policy.

We commit to an inclusive recruitment process and equality of opportunity for reputed company our job applicants.

At reputed company, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold reputed company, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. reputed company you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

reputed company is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national reputed company, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to reputed company and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.