Executive Director, Clinical Trial Management

Executive Director, Clinical Trial Management

Syneos Health

Home-based, Spain

Job responsibilities

  • Provides expert monitoring strategy, oversight and guidance to support internal teams and sponsors. Includes defending the rationale for monitoring strategy, process and tools and maintaining expert-level current knowledge of industry trends and “current-thinking”. May represent Syneos Health at industry events, through publications and other contributions to thought leadership in the industry;
  • Guides internal teams and sponsors through and documents the key decisions needed to implement a high quality, efficient risk-based monitoring (RBM) solution. This includes close interaction with project management, data management, quality assurance, biostatistics, medical monitoring and data operations technical support (DOTS);
  • Sets expectations for and oversees the identification of critical data and process, the assessment of risks to protocol execution and clinical delivery, risk and issue tracking and risk and issue mitigation strategies;
  • Where sponsors desire to incorporate new data sources, technologies or new/supplemental/substitute processes to support RBM, strategizes with internal team members and sponsors to agree on "hybrid" approach that is efficient and effective;
  • Works with internal team members and sponsors to ensure access to data needed to execute RBM according to the agreed plan;
  • Provides expert operational oversight and guidance to support prioritization of activities, reviews and monitors the work performed, metrics compliance, and development of contingency plans, among others. This expertise should extend from site activation through database lock;
  • Analyzes performance and quality metrics to assure BU achievement of quality and compliance expectations related to patient safety and data integrity as well as RBM success measures;
  • Functions as point of escalation for clinical, central monitoring, RBM and project risks and issues. Oversees progress of teams supporting clinical projects. Ensures individual and team tasks are completed according to requirements per Sponsor/Customer expectations and contract;
  • Leads work streams to support the development and implementation of new initiatives and strategic direction of the BU, cross-BU Clinical Operations and cross-functionally;
  • Ensures quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WI) and compliance with federal and local guidelines and ICH GCP;
  • Oversees progress of teams supporting clinical projects;
  • Ensures individual and team tasks are completed according to country/region specific and government regulations and per Sponsor/Customer expectations and contract;
  • Develops and supports customer relationships, manage customer expectations and escalates more serious risks and issues as required;
  • Works closely within appropriate business unit/region to ensure staff performance on studies and corrects deficiencies as identified by staff, clients, and auditors;
  • Identifies needs and may make recommendations for process improvement and efficiencies. Seeks appropriate approval for initiating and leading workstreams to avoid duplication or competing budget/resources;
  • Participates in committees and work groups to support the development and implementation of new initiatives and strategic direction of the BU and cross-BU Clinical Operations;
  • Provides support to Business Development to facilitate new project awards during the Bid Defense process, providing expert Clinical Operations guidance where required;
  • Participates in marketing activities, client presentations and proposal development;
  • Line Management responsibilities including administrative oversight, professional development, performance appraisals, and mentoring/counseling of staff;
  • Manages staff by establishing goals that will increase knowledge and skill levels, and by delegating tasks commensurate with skill level;
  • Liaises with resourcing management on active awarded and proposal project assignments;
  • Reviews workload, utilization, productivity, and quality for staff in reporting chain;
  • Manages the resource availability for the assigned staff, ensuring projects are suitably resourced and staffing needs are identified in a timely fashion, resolving potential resourcing conflicts to facilitate mutually beneficial resolutions;
  • Supports the assessment of overall staff growth and actively participate in the selection and hiring process;
  • Proactively works to ensure staff retention and turnover rates remain within expected levels;
  • Ensures all staff follows required training and completes the required documentation;
  • Provides regular compliance updates to management accordingly;
  • Participates in audits of clinical trial management delivery and prepares others for participation in audits;
  • Actively pursues opportunities to represent the business at industry conference and through writing white papers and other thought-leadership activities.

Qualifications

What we’re looking for

  • Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience;
  • Master's degree or health data sciences degree preferred;
  • Expert in Good Clinical Practice/ICH E6 (R2) Guidelines and/or other applicable regulatory requirements;
  • Expert in Risk-Based Monitoring Strategies, processes and tools preferred;
  • Expert in project risk and issues management;
  • Knowledge of and relationships with industry thought-leaders in RBM and risk and issue management;
  • Strong experience interacting with sponsors, including experience handling conflict and difficult conversations;
  • Strong ability to persuade and influence both above and below as well as internal and external;
  • Strong experience in operational efficiency and using data and metrics to drive performance and decisions;
  • Must demonstrate good computer skills and be able to embrace new technologies;
  • Mastery of MS Excel (sorting, filtering, calculating, pivoting);
  • Mastery of Analytical Data Visualization Tools (adjusting visualizations, selecting subsets of data to analyze, identification of trends and outliers);
  • Knowledge of statistical analysis techniques, visualizations and tools (Cluepoints, Medidata-CSA, Hy's Law, Funnel Plots, Box and Whiskers);
  • Knowledge of Lean Six Sigma, RACT tools;
  • Strong analytical skills and well-developed understanding of statistical concepts;
  • Well-developed therapeutic expertise;
  • Excellent verbal and written communication skills;
  • Strong negotiation skills, organizational skills and problem-solving skills;
  • Demonstrated strong leadership, tactical and strategic thinking skills;
  • Ability to anticipate and address critical issues; and develop contingency plans in a proactive manner;
  • Strong background in financial concepts as related to forecasting, budgeting, and proposal generation;
  • Strong background in management of utilization, resources, hiring targets and productivity metrics;
  • Demonstrate understanding of the workflow process, roles and responsibilities of multiple functional areas, and ability to work across those functional areas. Ability to understand, explain and communicate project concepts and put into detailed plans;
  • Ability to teach, train and mentor employees of all levels to achieve project, departmental, personal and organizational goals;
  • Requires above average attention to detail, accuracy, and organizational, interpersonal, and team-oriented skills. This includes excellent communication and presentation skills, both written and spoken, with an ability to inform, influence, convince, and persuade;
  • Comfortable making tough decisions independently and communicating those decision and the rationale internally and externally. Accepting responsibility for the project delivery and financial performance through their reporting line and demonstrating a strong personal accountability for performance and delivery of the departmental goals;
  • < 30% travel (departmental meetings, investigator meetings, training, client meetings and bid defenses).

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© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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