Job Description

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.

Summary:

The Senior Manager, Clinical Operations Asia oversees and manages regional clinical development activities in this designated region to ensure quality and timely performance of all investigational site activities and study file management for clinical studies conducted by Pharm-Olam in this region. This individual will be responsible for building a high-performing regional clinical operations team, developing and managing the regional departmental budget, and for the technical leadership and successful execution of projects in accordance with regulatory requirements.

In addition, this individual will be responsible for the Identification, Operational Assessment, Selection and Operational Oversight of Vendors in the APAC region.

Key Responsibilities:

• Ensures that the Company\xe2\x80\x99s internal procedures are followed and are not in conflict with local legislation.
• Evaluate and determine regional clinical operational trial resources and resource strategies, including maintenance of Monthly Allocation Forecast (MAF) tool to determine staffing needs for trial management, including personnel requisitions, hiring and assignments.
• Lead and participate in the selection and on boarding process for new staff by conducting candidate review and participating in the interviewing process.
• Attract, retain and foster individual development of key personnel for continued success in current and future assignments by providing resources and opportunity for appropriate training, mentoring or other experiences.
• Lead and motivate employees, provide feedback, coaching and counselling to enhance or improve performance by setting expectations and holding individuals accountable for performance and behaviour.
• Review Business Development activities within the region and support Requests For Information and Proposals, direct regional feasibility and country selections, review bids and communicate potential projects to Clinical Operational Managers to ensure adequate resources are in place.
• Liaise with Business Development to ensure smooth handover of clinical studies to ensure consistency, timeliness and quality of all study.
• Provide strategic planning and site selection, negotiations and patient recruitment planning, including review of project specific metrics to ensure regional projects are managed and investigators and sites are well supported.
• Liaise regularly with all departments working closely to ensure Project Management Department deliverables are consistently met for all projects and are appropriately conducted by attending Project Review meetings.
• Provide oversight and support to study team leaders and managers through coaching, mentoring, supervising, and developing/training.
• Manage the quality of assigned staff\xe2\x80\x99s work through regular review and evaluation of work product. Ensure that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by management.
• Identify quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff.
• Maintain current knowledge of, and ensure all team activities arising or occurring within the designated region are conducted in compliance with the full range of related internal and external systems, technology, regulatory requirements and related policies and procedures.
• Advocate potential process improvements. Lead the establishment and implementation of best practices and continuous improvement in collaboration throughout the organization. Ensure consistent communication and distribution of information and relevant process changes including updates to training curriculum.
• Effectively communicate with and influences individuals at all levels of the organization. Serve as a key conduit in effectively communicating organizational information through the departments.
• Work towards identification of suitable vendors for operational needs in the APAC region in consultation with Regional Head for Clinical Operations in APAC.
• Perform a thorough Operational Asessment and Selection of suitable Vendors in the APAC region depending on organizational and project needs.
• Support QA with coordination for vendor qualification audits, as needed in APAC.
• Provide Operational oversight to APAC vendors and their assigned resources to ensure they have been appropriately captured in the vendor contractor database, relevant access provided, relevant operational SOPs, Policies and other trainings have been assigned to them.
• Oversee non-project specific training compliance for operational vendor resources in APAC.
• Coordinate with Vendor\xe2\x80\x99s QA team for CAPA responses to Audit findings and ensure completion of data entry in QMS.

• Reports to the Director, Clinical Operations-APAC and Country Manager - India
• Supervise all clinical personnel in his/her assigned region directly or indirectly
• Collaborate with Pharm-Olam non-Operational Department Heads, including but not limited to: Legal, Finance, IT, Human Resources, Business Development, Client Relations, Compliance, Training and support staff personnel
• Line manage staff within his/her region
• Collaborate with project teams and Pharm-Olam cross-functional operational departments, including but not limited to: Clinical Operations, Project Management, Data Management/Systems, Biostatistics, Regulatory Affairs, Medical Montioring, Medical Writing, Vendor Management and Quality Assurance
• Liaise with Sponsors, Investigators and sub-contractors/ APAC Vendors

• Life Sciences and/Bachelor\xe2\x80\x99s Degree in a healthcare or Nursing/Medical background or scientific discipline preferred.
• 7 years of experience working on clinical trials with 4 years\xe2\x80\x99 experience in a leadership capacity or equivalent combination of education, training and experience.
• Advanced knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
• Strong written and verbal communication skills. English fluent.
• Effective communication, organizational, and interpersonal skills.

• Excellent knowledge of clinical trial structures and organizations.
• Proficient in the use of computer and software systems including use of Microsoft Word, Excel and PowerPoint.
• Ability to establish and maintain effective working relationships with co-workers, managers and clients.

• Effective time management. Ability to develop, organize and manage multiple tasks.
• Ability to deal with competing priorities. Strong reasoning and creative problem solving skills.
• Strong leadership and management skills.
• Excellent decision making and presentation skills.
• Ability to work independently.

• Ability to travel as required both locally and internationally.

Allucent