Senior Manager, Global Clinical Monitoring
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Precision Medicine GroupClinical Research
Remote, United StatesFull-TimeManager
Salary133,900 - 200,900 USD per year
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Job Details
- Experience
- At least 10 years or more in clinical operations, data management or related discipline either in CRO or Pharmaceutical industry with a minimum of 5 years onsite monitoring experience. 5+ years of direct supervisory experience managing CRAs
- Required Skills
- MentoringCoachingData management
Requirements
- Graduate, postgraduate, 4-year college degree, or equivalent experience ideally in a scientific or healthcare discipline
- At least 10 years or more in clinical operations, data management or related discipline either in CRO or Pharmaceutical industry with a minimum of 5 years onsite monitoring experience.
- Monitoring experience includes use of electronic data capture systems as well as paper and electronic medical records.
- 5+ years of direct supervisory experience managing CRAs is expected in candidates for this position
- Experience creating effective development programs for clinical staff.
- Experience developing evaluation processes, performing gap analysis, and ensuring all clinical staff are properly trained to perform their duties consistent with Precision for Medicine quality standards
- Ability to drive and availability for domestic and international travel including overnight stays, with an expectation of travel approximately 25%.
- Demonstrates mastery knowledge of ICH-GCP, applicable local regulatory requirements, relevant Precision for Medicine SOPs, technical CRA knowledge of all phases of study (including remote monitoring and clinical data review) as well as regulatory guidance.
- Deep knowledge of how clinical research centers operate along with the ability to teach CRAs to solve site and execution related problems at the site level.
- Demonstrates understanding and ability to work with EMRs and EDCs
- Highly organized, ability to set priorities and possesses excellent problem solving skills.
- Understands clinical trials methodology, including a working knowledge of protocols and indications being studied.
- Ability to develop, coach and mentor CRA and GCM Management staff.
- Communicates both verbally and in written form in an acceptable manner.
- Conducts formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency.
Responsibilities
- Generate action plans and provide developmental/strategic oversight to optimize CRA services, with a focus on high quality delivery of individual/team/departmental goals.
- Assist with and contribute to project resourcing to ensure proper level and allocation resource is assigned for each project within a region/area (with respect to project phase).
- Collaborate with the Clinical Team Leads/Clinical Trial Managers and Clinical Operations Management Team to ensure that resource needs and site requirements are met appropriately.
- Develop, mentor, manage and coach CRA staff and if applicable, GCM Managers to progress their skills so that Precision for Medicine quality standards are maintained.
- Perform accompanied site visits to assess CRA skills and developmental needs, as well as assist CRAs with project specific issues.
- Identify quality risks and issues and recommend corrective action plans as needed to leadership team to address deficiencies in performance of employees.
- Ensure that all staff have the proper resources, training, materials, and access to systems to deliver on the expectations of their position.
- Ensure CRAs provide timely and accurate updates of all required administrative material (SOPs, T&E, etc.) on company systems.
- Work with the Clinical Operations Management Team to continually improve and enhance CRA expectations and procedures to promote quality, consistency and efficiency in execution.
- Manage CRA staff and if applicable, GCM management staff in accordance with Precision for Medicine’s values and policies.
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