CATO SMS and Pharm-Olam, LLC have merged to form Allucent!
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.
The Manager, Study Start-Up will provide leadership, mentorship, training and career development for assigned staff in the Global Regulatory team to assure the objectives of Allucent and the sponsor are met. The Manager, Study Start-Up will provide guidance to ensure that staff fulfil responsibilities, to the company and the client, in accordance with company policies and procedures, SOPs, ICH/GCP guidelines, FDA regulations and local regulatory bodies.
The Manager, Study Start-Up supports the department and CTO related systems and process improvements and development of (new) services to contribute to building a high performance organization, Allucent reputation and growth.
The Manager, Study Start-Up is a member of the Study Start-Up amp; Site Intelligence Management team. The Manager, Study Start-Up manages the day-to-day functional and organizational activities for the assigned team by:
- Defining and managing (future) project resource needs to meet project milestones
- Reviewing the budgeted and recorded hours to ensure they are within acceptable working limits for active studies. Where needed, implements mitigation / improvement plans
- Overseeing and managing the team’s project allocation, utilization and workload
- Assisting the team in managing time and tasks to adhere to study budget and timelines, while achieving quality, compliance and efficiency
- Participate in the recruitment process (requisition opening, interviews, evaluate candidates, hiring decision)
- Keeping oversight to ensure compliance to the SOPs and ICH/GCP/regulatory guidelines and best practices as well compliance to the department and project metrics. Where needed, supports course of action to achieve/ sustain compliance and efficiency
- Contributing to Study Start-Up amp; Site Intelligence systems and process improvement initiatives.
- Is an active member of the Study Start-Up amp; Site Intelligence management team
To achieve a high performance team, quality in the project specific service deliverables, and as a result, contributing to Allucent reputation and growth, the Manager, Study Start-Up:
- Conducts dedicated line management, including performance management and performance evaluation/appraisals for direct reports.
- Identifies, plans and executes staff training meetings, as well as contributes to design of and delivery of training curriculum
- Manages staff onboarding and probation period evaluation
- Manages staff career development and promotion, including succession planning
- Nurtures a stimulating working environment, safe environment, collaborative spirit and open culture as per Allucent values to enhance staff engagement and development
- Drives / Supports compliance to Study Start-Up amp; Site Intelligence department KPIs
- Actively facilitates knowledge sharing and lessons learned to achieve continuous improvement, and supports process improvement initiatives
- Contributes as Subject Matter Expert (SME) in the field of Study Start-Up to the company’s Regulatory Intelligence as well as evaluation/improvement of processes and procedures including underlying instructions and templates within the Quality Management System
- Supports the Study Start-Up amp; Site Intelligence Management team in analyzing audits, inspections, quality incidents, project issues, metrics and trends observed to contribute to building a high performing team and learning organization
- Builds a culture where staff cross reference regulations / QMS / protocol and study plans to secure compliance and quality while working efficiently
- Supports audits / inspections and department CAPAs
- Life science, healthcare and/or business degree
- Minimum 7 years of experience in drug development and/or clinical research
- Previous experience in a line management role preferred
- Excellent knowledge of ICH/GCP, FDA and country regulations
- Strong customer service orientation
- Demonstrated professionalism and presentation of a positive image of the company
- Demonstrated understanding of applicable medical/therapeutic area knowledge and medical terminology
- Great communication and listening skills, confronting constructively
- Fosters learning and the advancement and development of others
- Representative, outgoing and client focused
- Effective organizational, managerial, and time management skills
- Strong analytical and problem resolution skills
- Demonstrated ability to lead by example
- Demonstrated personal integrity and ethical values
- Demonstrated ability to see the bigger context and act appropriately
- Ability to establish and maintain effective working relationships with co-workers, managers, direct reports, internal and external clients
- Ability to work in a fast-paced challenging environment of a growing company
- Proficiency with various computer applications such as Word, Excel, and PowerPoint required as well as CTMS.
- Comprehensive benefits package
- Competitive salaries per location
- Departmental Study/Training Budget for furthering professional development
- Flexible Working hours (within reason)
- Opportunity for fully remote working or Hybrid Working Model
- Leadership and mentoring opportunities
- Internal growth opportunities and career progression
- More task variety
- Financially rewarding internal employee referral program
- Access to online soft-skills and technical training via GoodHabitz and internal platforms
To all recruitment agencies: Allucent does not accept agency resumes. Please do not forward resumes to our careers alias or other Allucent employees. Allucent is not responsible for any fees related to unsolicited resumes. #LI-MH1