Associate Director, Clinical Trial Manager RWLP ** Homebased POLAND **

Associate Director, Clinical Trial Manager RWLP ** Homebased POLAND **

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

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 deliver – for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

• 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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• •We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

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”.

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 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.

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 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.

Represents the business at industry conference and through writing white papers and other thought-leadership activities.

QUALIFICATION REQUIREMENTS;

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.

Experience interacting with sponsors, including experience handling conflict and difficult conversations.

Demonstrated 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).

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