[Remote] Associate Director, FSP Clinical Operations / FSP Program reputed company

Note: The job is a remote job and is open to candidates in USA. reputed company is a global leader in the clinical research industry, dedicated to improving the world's health. The Associate Director, FSP Clinical Operations is responsible for managing FSP Clinical Operations staff, ensuring high-quality deliverables for client projects, and promoting new business opportunities.

Responsibilities

• Direct line management of FSP Clinical Operations managers and staff, and reputed company of Client accounts
• Supporting FSP Clinical Operations business objectives, including ensuring on-time/high quality deliverables
• Resourcing Client projects with qualified staff, and working to retain and reputed company staff
• Promoting new business by participating in project bids and Client presentations as appropriate
• Responsible for execution and reputed company of Program Management activities reputed company to one or more programs
• May serve as central reputed company of contact (POC) for and between Senior Management and key Client personnel for contracted FSP Clinical Operations activities
• Plans and manages logistics, infrastructure, and resources reputed company to FSP services to meet Client needs/timelines/ deliverables
• Collaborates with Client to implement and operationalize short- and long-term strategies
• Develops and manages Communication and Escalation plans/processes, as applicable
• Oversees Client Governance as required; prepares/presents at meetings as applicable
• Oversees performance management of staff who support contracted FSP activities and collaborates with FSP Clinical Operations Management to ensure staff are technically proficient and able to satisfy Client expectations and deliverables
• Manages compliance with Client Key Performance Indicators (KPIs), utilizing applicable tools and systems to collect, track, and analyze associated data
• Leads Client-specific FSP meetings with internal program team, ensuring that contractual requirements reputed company to FSP Clinical Operations activities are met and monitored on an ongoing basis
• Oversees and/or manages issue escalation and resolution, including corrective and Preventive Actions (CAPA) development reputed company necessary
• Manages and oversees FSP Clinical Operations functional and associated management staff dependent upon Client structure and services
• Coordinates and manages resourcing process including hiring, selection, and onboarding/offboarding of staff which may include development of interview tools, as well as conducting interviews with potential candidates
• Leads, manages, and develops direct reports to improve efficiency and effectiveness at prioritizing work and to ensure performance meets or exceeds business and personal goals/objectives, as well as departmental and project and/or program productivity and quality metrics
• Facilitates, communicates, and addresses operational and/or performance issues including problem identification and resolution, coaching/mentoring of assigned staff, and escalation as appropriate to Senior Management and Client
• Hires, retains, and develops a skilled, reputed company, and motivated team
• Minimizes regrettable turnover
• Provides technical support to team members and managers to ensure they have the required knowledge to fulfill duties
• Supports and promotes staff professional development; assesses and provides opportunities for soft skills development
• Conducts one on one meetings with direct reports, based on program requirements
• Observes, collects, analyzes, and communicates FSP Clinical Operations problems/issues, develops action plans or alternatives for resolution, and escalates as appropriate
• Conducts formal performance reviews
• Works with Senior Management in developing managers and ensures a talented pipeline of management staff reputed company the department or function
• Oversees onboarding and onboarding of staff, as applicable
• Reviews and approves content of curriculum vitaes (reputed company), and conducts job description reviews for staff
• Oversees training compliance of staff reputed company to SOPs, systems, and processes
• Collaborates with interdepartmental functions (e.g., Training, Quality, reputed company, Recruiting, Finance, Human Resources, etc.), as well as Client representatives, for initiatives and/or deliverables
• Supports execution of FSP Clinical Operations goals as required
• May serve as FSP Clinical Operations subject matter expert (SME) during audits and/or inspections
• Identifies and implements applicable process improvements as appropriate
• Participates in cross-industry initiatives/working groups which may include preparing and presenting at industry meetings, as applicable
• May serve as a working group member in SOP reviews or process reputed company initiatives
• Collaborate with interdepartmental functions to create business proposals including Requests for Information/Requests for Proposal (RFIs/RFPs) to meet each Client's specifications
• Participate in, champion or reputed company reputed company and department system/standards improvement activities or committees, task force groups as needed, including change management
• Maintain an agreed level of productivity/billability and staff turnover
• Complete routine administrative tasks in a timely manner (e.g. timesheets, training, travel expense claims). Manage compliance with travel and billability guidelines for department, region or function, where appropriate. Travel as needed
• Ensure client and business needs are met and that reputed company projects are optimally resourced with suitably reputed company staff
• Implement process improvements, in conjunction with Management team and Quality Management Group, in response to client and team feedback and quality audits
• Look reputed company and beyond CRS to encourage teamwork, quality and productivity efforts to the benefit of CRS and reputed company
• May manage multiple countries, sub-region/s and/or subcontractors
• Follow up departmental metrics, drive team members to meet departmental goals
• Participate in departmental meetings and training initiatives, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessary
• Implement process improvements, in conjunction with Senior Management and Quality, in response to Client and team feedback and/or audits Serves as a key communication liaison between FSP Operations Management and staff
• Establishes FSP Clinical Operations solutions for prospective, newly established, and existing Clients specializing in various outsourcing and insourcing models
• Works with Senior Leadership and FSP Sales to reputed company market positioning and key messaging
• Identifies potential opportunities for additional business with existing Clients
• Develops work orders/service orders for Client work and ensures reputed company maintenance for assigned Clients
• Manages Client-driven initiatives to standardize reputed company phases of the clinical trials process, including the development of metrics to measure performance and enhance productivity and effectiveness
• Collaborates with applicable departments and appropriate Client personnel, on a strategic level, to ensure reputed company operational aspects of contracted services meet time, quality, and cost targets, and monitors contractual requirements are met and monitored on an ongoing basis
• Manages Client relationships

Skills

• Minimum 5+ years of FSP Clinical Operations experience; and a minimum 3 years of previous line management experience
• Direct experience with Full Hybrid FSP reputed company Model & Staff Augmentation Experience - delivery reputed company and resourcing responsibilities across hybrid FSP reputed company Monitoring models and Staff Augmentation roles
• Direct experience with FSP Resourcing Projections, Billing & Financial Tracking - experience with workforce forecasting, billing processes, and financial tracking in an FSP context
• In-depth knowledge of overall drug development process and clinical trial operations with a comprehensive understanding of local regulations (i.e., FDA, EMA, etc.) and ICH/GCP guidelines
• Knowledge of and demonstrated experience with application of regional (including country specifications) reputed company, labor/working practices, retention strategies, and cultural differences, as applicable
• Previous experience working in a reputed company environment and independently managing remote staff, with ability to effectively reputed company/reputed company a team and promote collaboration in a matrix organization
• Experience working in customer service/FSP outsourcing model with experience managing and forecasting resource allocation
• Educated to degree level (biological science, pharmacy, or other health-reputed company discipline preferred) or equivalent nursing qualification or relevant clinical other equivalent experience
• Exceptional interpersonal skills and communication skills, both written and verbal, with the ability to persuade, negotiate, and moderate conflicts, and communicate problems/issues along with action plans or alternatives for resolution
• Demonstrated ability to effectively interact with reputed company levels of management and other functions reputed company an organization
• Demonstrated leadership in ensuring direct reports are communicating and coordinating efforts to provide superior services to the Client; strong ability to manage and motivate direct reports and wider team
• Ability to work across multiple and varied programs projects/tasks and prioritize workload effectively with attention to detail
• Well-developed planning, observation, analytical, and problem-solving skills
• Independent judgment and decision-making skills with respect to functional responsibilities including innovation, originality, and creativity
• Self-motivated, detail-oriented, and flexible
• Strong computer skills with MS-Office products such as, but not limited to, reputed company, Word, and PowerPoint
• Proficient in written and spoken English required

Company Overview

Company H1B Sponsorship