Description
Assoc Dir, Clinical Trial Mgmt- RWLP Mexico or Argentina Home BasedSyneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
Job Responsibilities
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).•
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 operational oversight and guidance to support prioritization of activities, reviews and monitors the work performed, metrics compliance, and development of contingency plans, among others.•
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.•
Participates in 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 correct deficiencies as identified by staff, clients, and auditors.•
Identifies needs and may make recommendations for process improvement and efficiencies.•
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.•
Support 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.
Qualifications
Education Requirements
Familiar with Good Clinical Practice/ICH E6 (R2) Guidelines and/or other applicable regulatory requirements.•
Familiar with Risk-Based Monitoring Strategies processes and tools preferred.•
Familiar with project risk and issues management.•
Experience interacting with sponsors, including experience handling conflict and difficult conversations.•
Ability to persuade and influence both above and below as well as internal and external•
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).•
Familiar with 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.•
Familiar with financial concepts as related to forecasting, budgeting, and proposal generation.•
Familiar with 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 with consultation as necessary and communicating those decisions 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)
Ten (10) years of clinical research experience with three (3) or more years in oversight of clinical deliverables. One (1) year experience in central monitoring/risk-based monitoring and three (3) years experience in a customer-facing capacity is preferred.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
http://www.syneoshealth.com
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Summary
Provides leadership, direction and management to Clinical Trial Managers (CTMs/Sr CTMs). Oversees the quality related to monitoring and site management activities to ensure clinical deliverables are met. Acts as primary point of contact for monitoring strategy and alignment both internally and externally for assigned studies. May liaise with other departments or business units to optimize resources as well as to harmonize central monitoring and clinical operations practices, processes and tools. Contributes to operational initiatives and continuous improvement. Uses, metrics, dashboards and reports to analyze compliance and quality of services to ensure clinical operations/central monitoring delivery, manages escalated project and site related matters to drive follow-up action plans and improve departmental procedures. Participates in the financial review of project status and drives project financial performance, particularly as related to clinical operations/central monitoring services.
