Manager, Clinical Operations / Senior Manager, Clinical Operations

Description

Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies.

These customers have new therapeutic ideas, but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in patients’ lives.

We are looking for an experienced Manager, Clinical Operations / Senior Manager, Clinical Operations, located in the USAto join our Team.

Key Responsibilities:

Manage CRAs in The Americas to be the Operational Team of choice for Principal Investigators and Sponsors by providing best in class operational staff to deliver clinical trial success by a commitment to quality standards, ease of working and ready to embrace innovation to optimize our processes. This role is responsible for supporting daily activities of staff members in order to ensure all projects are completed on time, in budget and in compliance with all standards. This includes resource and performance management in order to maintain sufficient, qualified, competent and well-coached teams. The manager nurtures a stimulating working environment and creation of exciting opportunities for staff (personal) development and growth. The manager is also in charge of staff project resourcing allocations. In addition, the manager is part of the department's management team and is actively involved in department and CTO/GCO related procedures, systems and deliverables in order to achieve a high performing team, quality in project specific service deliverables, and as a result, contributes to overall reputation and growth. The manager is also driving the implementation of new services and approaches based on developments in the industry. The Manager drives quality improvement activities as a result of audits / inspections / quality incidents / project issues / metrics / trends observed and may support business development activities and cross department initiatives

Department Management / Quality

• Participate to GCO Meetings.
• Based on audits / inspections / quality incidents / project issues / metrics / trends observed, runs analytics, drives actions and presents at regional / global level in order to share knowledge and ensure taking lessons learnt in order to contribute to building a high performing team and learning organization
• Contribute Quality topics – Inspections and External and Internal Audits – ensuring quality responses to each case action demanding GCO contribution.
• Drives process improvement initiatives
• Escalate any appropriate issues to Regional Department Leader to ensure quality is met and actions are monitored until resolution is agreed and met.
• Participate in Internal Projects to improve process or develop new business practices.
• Contribute to monthly reports to Department Head.

• Deal with internal stakeholders and clients to allocate CRAs to projects.
• Resource forecasting needs
• Computer skills including proficiency in use of Microsoft Office, CTMS, eTMF and EDC.
• Contractor compliance
• Minimum 7 years' relevant clinical research experience in a CRO or industry related environment, including experience working in a CRA/SCRA role.
• Staff succession planning
• Expense report and timesheet compliance
• As needed participates in audits / inspections and driving department CAPAs
• Ability to manage multiple projects and strong attention to detail.
• Access to online soft-skills and technical training via GoodHabitz and internal platforms
• Secures staff compliance to:
• Proven flexibility and adaptability.
• Wiling to travel as needed for CRA assessment visits, meetings, etc.
• More task variety
• Conduct of co-monitoring visits including analytics
• Monitors employee utilization, workload, and overtime hours, annual holiday.
• Engagement and stability in teams
• Act as back-up for colleagues in SM management team
• Ability to work in a team or independently and to effectively prioritize tasks.
• Flexible Working hours (within reason)
• Effective Leadership, Coaching and Mentoring Skills
• Conducts analytics and reporting of staff utilization and profitability and implements mitigation / improvement plans
• Client focused; proactive and solution oriented
• Other responsibilities as required.
• Manage contractors
• Departmental Study/Training Budget for furthering professional development
• Competitive salaries per location
• Propose policies to ensure CRA engagement.
• Line management of CRAs
• Resolve client-face conflicts with CRA allocations if Project Teams requests support.
• May support internal strategies and developments to support a solid framework of operation required for the execution of the CTO service deliverables.
• Advanced knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
• Engage with external stakeholders involved in Clinical Trials execution.
• Financial and business acumen, administrative excellence and analytical skills
• Staff workload management
• Ensure CRAs work following Allucent SOPs, Working Instructions and Study Specific Processes.
• Strong 2 years' direct Line Management experience managing and recruiting CRA/SCRAs.
• Builds a culture where staff cross reference regulations / QMS / protocol and study plans to secure compliance and quality while working efficiently
• Internal growth opportunities and career progression
• Contribute within the CRA recruitment process to ensure quality of the selected candidates.
• Ensure Country Readiness in those Therapeutics Areas Pharm-Olam focuses on.
• Bachelor's degree or combination of education and experience.
• Financially rewarding internal employee referral program
• Initial company CV and recurrent CV update
• Drives the development and maintenance of SOPs and (uncontrolled) templates to ensure the appropriate operational framework of the SM / CTS operations is in place and ensures all related procedures and work instructions remain current
• Probation period evaluation
• Support Project Teams with Site Selection and Recruitment Strategies in the Country.
• Fluent in English, written and verbal
• Effective organizational and time management skills.
• Ability to establish and maintain effective working relationships senior management, peers, direct reports, and clients.
• Propose process to ensure CRA professional development for current CRAs and potential external candidates through the CRA Academy.
• Recruitment (opening reqs, interviews, evaluate candidates, takes hiring decision)
• Manage the monthly CRA Allocation process to projects to ensure a quality MAF every month and weekly updates whenever needed.
• Staff project allocation
• As needed, participates in client facing conversations including capabilities presentations, bid defenses and service demonstrations
• Review and analyse timesheet vs project allocation vs time (budget) available
• Maintain ongoing awareness of developments with the clinical development field.
• Mature management skills demonstrated by calm and thorough review of situations. Seeks to understand all contributing factors. Proposes, implements, and evaluates appropriate resolutions.
• Staff training compliance
• Effective oral and written and presentation communication skills, with the ability to communicate effectively with medical personnel.
• Strong experience in all phases of global, full-service clinical trial delivery lifecycles (Start-up, Maintenance, Close-out), oncology, rare diseases, CNS, first in human, dose finding studies, etc.
• Staff onboarding
• Comprehensive benefits package
• Leadership and mentoring opportunities
• Ability to proactively identify and resolve issues in a timely manner.
• Staff retention and engagement
• Develops and provides role specific training
• Performance management: objectives, mid-year and end-year evaluation, management of underperformance
• Assures good communication and relationships within SM, CTO and other stakeholders in the company
• Staff career development and promotion
• Strong customer service orientation.