Manager, Global Clinical Monitoring – CRA Line Manager

This is a fully remote position, open to applicants in Australia.

📋 Description

• Formulate action plans and offer developmental and strategic guidance to enhance CRA services, emphasizing the high-quality achievement of individual, team, and departmental objectives.

• Aid in and contribute to project resource allocation to guarantee the appropriate level and distribution of resources assigned to each project based on its phase. Update tracking systems and collaborate with project teams.

• Work alongside Clinical Team Leads, Clinical Trial Managers, and the Clinical Operations Management Team to ensure that resource needs and site requirements are effectively addressed.

• Develop, mentor, manage, and coach CRA personnel to enhance their skills, ensuring adherence to Precision for Medicine's quality standards.

• Promote individual career development and emphasize personal responsibility and accountability.

• Conduct accompanied site visits to evaluate CRA skills and developmental requirements, and assist CRAs with project-specific challenges.

• Identify quality risks and issues, and propose corrective action plans as necessary to the leadership team to rectify performance deficiencies among employees.

• Ensure that all staff members have the appropriate resources, training, materials, and system access to meet their position expectations.

• Confirm that CRAs provide timely and accurate updates of all required administrative documentation (SOPs, T&E, etc.) on company systems.

• Collaborate with the Clinical Operations Management Team to continually refine and enhance CRA expectations and procedures to foster quality, consistency, and efficiency in execution.

• Develop and maintain relevant metrics for CRA resource oversight, and partner with the Clinical Operations Management Team to assess these metrics.

• Engage in the recruitment process for new CRAs by reviewing CVs and participating in interviews.

• Facilitate onboarding training for new CRA staff in collaboration with Human Resources, Clinical Training, and other functional areas.

• Represent Precision for Medicine professionally.

• Manage CRA personnel in alignment with Precision for Medicine’s values and policies.

• Additional responsibilities include assisting with planning, assigning, and directing work, as well as gathering performance feedback to inform appropriate action plans.

⛳️ Requirements

• Bachelor’s degree, postgraduate degree, 4-year college degree, or equivalent experience, preferably in a scientific or healthcare-related field.

• Significant experience in clinical operations, data management, or a related field within the CRO or pharmaceutical industry, with at least 5 years of onsite monitoring experience.

• Monitoring experience should encompass the use of electronic data capture systems as well as paper and electronic medical records.

• 3-5 years of direct supervisory experience overseeing CRAs.

• Proven experience in developing effective training programs for clinical staff.

• Experience in creating evaluation processes, conducting gap analyses, and ensuring that all clinical staff are adequately trained to perform their roles in line with Precision for Medicine's quality standards.

• Willingness and ability to travel domestically and internationally, including overnight stays, with an expected travel commitment of approximately 25%.

🏝️ Benefits

• We are committed to ensuring that employees feel valued for their contributions every single day.

• Your input will be welcomed, and your ideas will be appreciated and nurtured, fostering positive change within the company.