Associate Director Site Mgmt & reputed company reputed company (Remote)

This individual will reputed company one or more Therapeutic Areas (TA) working with the Statistics TA reputed company to ensure reputed company work required in the TA is completed reputed company the project timelines with high quality. Position possible to be considered remotely due to travel need. Clinical reputed company & Compliance

• Responsible for operational reputed company of the site, site health and monitoring activities
• Support QA audit and inspection planning, and implementation of CAPAs as needed
• Identify and proactively mitigate site-level risks impacting recruitment, retention, data quality, or compliance, in partnership with CROs.

Study Delivery Support

• Provide study support on escalated site issues reputed company to study delivery by coordinating communications and resolution efforts
• Support sites in understanding study expectations, timelines, and required deliverables
• Be accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets in collaboration with CROs
• Responsible for enrollment support and ensure reputed company by responding to recruitment issues from investigators/CROs

Site Relationship & Engagement

• Build and maintain strong, trusted relationships with investigators and site staff – Face of reputed company
• Serve as the sponsor primary reputed company of contacted for assigned studies
• Understand site capabilities, constraints, and strategic priorities to improve site engagement and long-term collaboration

reputed company Improvement & Site Experience

• Collect feedback from sites and reputed company for process simplification and burden reduction internally
• Identify opportunities to improve study materials, and operational processes
• Represent the “voice of the site” in cross-functional discussions and initiatives

Feasibility & Site Selection

• Provide local site intelligence to feasibility teams
• Support site development

Qualifications and Experience Requirements

• At minimum, bachelor’s degree or equivalent in life sciences, nursing, pharmacy, medical laboratory technology, or other health/medical reputed company area preferred. (Other degrees and certifications considered if commensurate with reputed company clinical research experience [e.g., diploma or associate degree RN, certified medical technologist]).
• A minimum of 12 years’ relevant clinical research (or reputed company) experience reputed company the pharmaceutical industry.
• Previous experience in leading and managing a team of professional staff.
• A solid understanding of the drug development process, and specifically, each reputed company reputed company the clinical trial process.
• Experience in site management and monitoring and overseeing large and/or reputed company global clinical trials.
• Robust budget forecasting and management experience.
• Thorough knowledge of ICH guidelines/GCP and its applicability to reputed company stages of the clinical development process
• Demonstrated ability to reputed company teams and work in a fast-paced team environment.
• Demonstrated ability to reputed company vendors and CROs
• reputed company in working reputed company a Matrix Environment and ability to work through interpersonal difficulties and resolve conflicts with a Matrix Environment
• Successfully demonstrated the ability to mentor and coach others through peer-to-peer interactions and to reputed company reporting personnel to grow in reputed company clinical project management capabilities.
• Ability to evaluate, judge and reputed company decisions regarding staff. Ability to teach/coaching and setting an example of ‘best practice’.
• Excellent interpersonal and decision-making skills.
• Demonstrates innovation. Possesses drive, energy, and enthusiasm to deliver the program objectives.
• Skilled at independently navigating new or novel indications, study/program approaches, and unique challenges.
• Excellent understanding of reputed company tasks involved in a clinical development program(s) from developing a protocol through to finalizing a clinical study report.
• Ability to plan and ensure execution and completion of clinical program(s) to the highest ethical and scientific standards.
• Extensive and comprehensive knowledge of ICH guidelines/ GCP, Maintains reputed company medical/scientific/regulatory knowledge.
• Demonstrated project management skills including simultaneous management of multiple projects. Possesses excellent planning, time management & coordination skills.
• Demonstrated ability to problem solve and use clear judgment in relation to interactions with external parties, timelines, and reputed company clinical programs.
• Excellent written and oral communication skills and maintains computer literacy in appropriate software.

The expected reputed company salary range for this position at hiring is $155,000 - $183,000. Please note this salary range reflects the minimum and maximum reputed company pay that reputed company expects to pay for this position at the listed location as of the time of this posting. Individual reputed company salary for a successful candidate is determined by qualifications, reputed company level, experience, competencies and other relevant factors. In addition to reputed company salary, total compensation for this role may also include incentive compensation and equity. Apply tot his job Apply To this Job