Manager, Clinical Operations

Avania are hiring – Manager, Clinical Operations

The role of Clinical Operations Manager is  responsible for overseeing the daily operations of the Clinical Research Associates (all levels), within a region with  responsibilities including  ensuring adequate project resourcing and employee workload.

This key appointment will manage a pan European team of 15 (Spain and Netherlands) with a focus on engagement, development and retention

The Manager, Clinical Operations role will;

Provide staff with expert clinical research and project operational advice. Leads the review and revision of departmental SOPs, working practice guidelines, and policies.

Collaborates with other department and/or functional groups to ensure consistency and/or improvement of processes, in order to address client complaints, audit findings, etc. Collaborate with other departments and regional teams on standardized KPI trackers/reports.

Ensures any project issues and results of discussions with Project Managers, are escalated appropriately to Director PM/Clin Ops.

Maintains awareness of overall development in the field of clinical research and ensures that staff remains current on clinical monitoring developments. Participate in the development of the clinical portion of client proposals including preparation of site start up and monitoring capabilities. May prepare and attend portions of capabilities and bid defense meetings.

Researching, analyzing, and identifying the priorities, needs, and requirements of the business and department. Based on this, create, and deliver new department initiatives, improvement plans and training. Assists Director, Clinical Operations with development of strategic departmental goals which correlate with corporate goals and formalize departmental action plans to meet those goals.

Conducts field evaluation visits with staff at sites. Lead project resourcing management for the team, reacting to customer requirements, presenting the staff member biography (providing a summary of qualifications), preparing them for the client interview, etc. Manage and provide support to the team on the customer feedback process.

Plans career development of staff. Holds regular one-on-one meetings with staff to discuss performance. Writes and delivers performance appraisals.

Identify and assesses training requirements for monitoring staff, identify gaps in knowledge and skills sets. Organizes appropriate training in liaison with the Onboarding & Training Specialist. Contribute to the development of LMS library of content (creating content & materials as needed), monitors and records subsequent performance to assess the effects of training on efficiency. Performs a periodic review of LMS content to ensure it is relevant and up to date.

Work with direct reports, cross dept. team members, and regional teams to streamline workflows and initiate workstreams that can be replicated as delegating process improvement opportunities, SOP creating/updates, report writing, training creation, etc.

Maintains an awareness of company policies to effectively represent the company perspective to staff. Creates a collaborative team environment focused on open communication, actively obtains team feedback, addressing concerns directly, and provides feedback up to leadership for visibility/actioning. Ensuring a smooth feedback loop back to the team to disseminate messages appropriately.

Develop and administer an effective on-boarding process for new Sr. CRA, CRA II, CRA I and/or CTA hires. Assist with on-boarding of team members across the larger clinical operations department as needed. Building action plans to address feedback as applicable.

Provides oversight of clinical deliverables and KPI's to ensure consistent and timely delivery, including prompt escalation and resolution of issues. Point of escalation for PM /Lead team on deliverables and quality results, drive actions related to performance management and close the feedback loop with the project team.

Proactively escalate resourcing concerns to Clin Ops leadership team, identifying needs and solutions (based on availability, skillset, therapeutic area, location, etc.). Proactively update FTE trackers as study timelines change

Candidates who offer a combination of the skills, knowledge and experience listed below are encouraged to apply to our Manager, Clinical Operations. With our continued growth we are hiring talent to join us on our journey and grow with us.

We seek -

• Bachelor’s degree with a preferred focus on a life science or healthcare related field.

• 1-5 years of experience managing direct reports, evidence of strong leadership, teambuilding, and hands-on management. Ideally gained within a CRO

• Comprehensive knowledge of ICH GCP regulations, as well as applicable regulations.

• Excellent communication skills with external vendors/CROs, cross-functional teams, and several different levels of the company including senior management.

• Proficient in the use of computer and software systems (Microsoft Word, Excel, PowerPoint, email)

• Ability to Travel

• Customer Focus

• Builds Networks

• Drives Results

• Ensures Accountability

• Situational Adaptability

• Balances Stakeholders

• Critical Thinking

• Develops Talent

• Directs Work

• Business Insights

• Drives Engagement

• Builds Effective Teams

We offer -

• The opportunity to work in an innovative, fast-growing and rewarding industry
• A dynamic and enthusiastic global team that fosters collaboration and the opportunity to work with experts across many specialties
• Exchange of knowledge and ideas to help employees grow and advance their careers, backed with training and other development opportunities
• Competitive compensation and benefits package (details shared during the interview process)
• Some roles offer the opportunities for travel
• Ask us about our hybrid and fully remote work opportunities

When you need to advance your career, it takes Avania 

We look forward to receiving your application!

•

Last updated on Oct 16, 2024