***Real World & Late Phase - Senior Site Mgmt Lead / Site Mgmt Lead - Western EU based
Lead the execution of the Site & Patient Services (SPS) components of Real World Late Phase Research (RLWPR) studies by applying clinical research expertise, exceptional decision making skills and innovative approaches to problem solving. Proactively set project goals and tangible expectations for SPS project team members.
- Oversee the delivery of Site Management project tasks, providing advice and guidance to achieve high performance and quality project deliverables.
- Ensure overall project efficiency and adherence to project timelines and financial goals; report metrics and out of scope activities.
- Develop, implement and maintain the Site Recruitment, SPS Operations and SPS Risk Management Plan within the agreed project strategy.
- Collaborate with other functional groups within the company such as data management, quality assurance and biostatistics where necessary to support milestone achievement and to manage study issues and obstacles.
- Manage and follow study activities through ongoing tracking and review of study progress. Provide input and report progress to appropriate SPS management and project management leaders.
- Act as the first line of escalation for site management questions and issues on assigned projects.
- Lead preparation for in-house audits and in creation of Corrective Action Plans (CAPAs).
- Develop and deliver presentations/training to clients, colleagues and professional bodies, as required.
- Participate in business development activities such as proposal development and bid defenses.
- May conduct co-monitoring and/or assessment visits as needed to ensure the study is being conducted in accordance with the protocol, SOPs, GCP and applicable regulatory requirements.
- May be assigned additional responsibilities as needed to support projects and other corporate/departmental initiatives.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Skill in understanding and executing complex study designs.
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.
Strong written and verbal communication skills including good command of English language.
Demonstrated team leadership and mentoring skills.
Demonstrated ability to develop and deliver project and functional training.
Excellent planning, organizational and problem-solving skills.
Ability to manage competing priorities and ensure on time, high quality delivery of project tasks/responsibilities.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor’s degree, preferably in a life sciences discipline, and 5 years of monitoring experience, together with proven team leadership experience; or equivalent combination of education, training and experience.
- Extensive use of keyboard requiring repetitive motion of fingers.
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
- Regular sitting for extended periods of time.
- May require occasional travel.
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