PPD Data and Quality Manager - Clinical Research in Chicago, Illinois

We are seeking a Data & Quality Manager to join our clinical research site in Chicago, IL!

  • Prepare individual/site OC plans and perform quarterly operational compliance check activities

  • Prepare associated reports and follow up on quality issues from all sources and related CAPAs

  • Perform regular quality control and oversee that quality of data is accurate, on time and adhere to Synexus SOPs, COP’s standards, GCPs, Local Regulatory and protocol

  • Validate and check quality of essential documents, participant files and site study data ensuring accuracy of data entered and source documents.

  • Maintain awareness of the latest approved procedures and ensure Synexus staff are following it.

  • Report and follow up with Site Director / Site Manager and operational staff on the status of quality activities and projects

  • Ensure confidentiality of staff, patient and sponsor matters.

  • Maintain all activities as required by Data Protection Act and Good Clinical Practice.

  • Attend to clients when called upon to provide study updates for the Country / Region as needed.

  • Plan and recommend resources to the Site Director / Site Manager to ensure deadlines are met on clinical projects and overall smooth running of the department.

  • Provide guidance for the data entry and query resolution process for studies

  • Develop, maintain and produce a dashboard for tracking patients, flow of CRFs and queries ensuring that this is provided in a timely manner.

  • Conduct, host, produce meeting minutes and actions for departmental and other relevant meeting ensuring that issues impacting on business are highlighted to the Site Director / Site Manager as needed.

  • Support the Synexus QA function with regards to notification, preparation and facilitation of client audit and regulatory inspections, investigations of quality issues and tracking and follow up of local CAPA status ensuring on time completion of quality related tasks.

  • Be Core Lead Data Coordinator on projects and deliver projects on time, within budget and to the client’s satisfaction.

  • Complete quality checks on Collaborate with CRAs/Internal/ external auditors/ Site Managers/Directors to ensure that DRS issues are dealt with appropriately and communicated to the relevant team members.

  • Complete other duties as assigned

  • Check Quality and Training processes to ensure appropriate timelines are met e.g. SQMS, CAPA, mandatory training.

  • Identify gaps in processes to improve clinical performance

  • Line management of the Data Coordinators Team, set goals and objectives and measure their performance

  • Deliver effective performance, talent and career management processes for the DC team

  • Prioritize daily workload for optimum quality and productivity in the DC team

  • Manage underperformance proactively in line with company policy

  • Ensure individual personal development and maintain positive staff morale.

  • Ensure all direct reports have clear direction, accountabilities, and levels of authority and job briefs.

  • Brief team at start of each year on objectives

  • Regular sessions with each direct report to review performance and to coach and develop skills in line with Synexus DPI to ensure they have necessary capabilities

  • Ensure regular team meetings are in place and actions taken

  • Monitor site operational team progress against individual targets at planned intervals and give constructive feedback (regular reviews)

  • Ensure the correct structure and roles are in place within sites in order to deliver business requirements

  • Recruit new team members following agreed company approach and ensure they are inducted effectively

  • Work with functional heads to achieve the above

  • Ensure regular site meetings to ensure clear communication channel providing both business and site information

  • Lead by example, acting in accordance with our values, developing and coaching your team with the goal of being a high performance group.

  • Ensure quality and patient safety are at the forefront of all activities through review and interpretations of audit reports, quality statistics and operating procedure robustness.

  • Ensure that there is a compliant, consistent working environment through robust implementation and oversight of standard operating procedures and work instructions

  • Ensure robust application and compliance with Good Clinical Practice at all times.

  • Ensure compliance with FDA, SOPs, GCPs, QA and all applicable Regulatory body guidance.

  • BS/BA degree and 2+ years of relevant work experience with increasing responsibility in data and/or quality management and knowledge of many therapeutic area, OR and equivalent combination of education and experience, is required.

  • Must have successfully been responsible for data entry and Investigator Site Files for multiple trials

  • Proficiency in using MS Office programs and web applications

  • Previous management experience is preferred

  • Demonstrated time management skills and ability to adhere to project productivity metrics and time lines.

  • Knowledge of clinical trial process and data management, clinical operations, quality management, and systems applications to support operations

  • Proven knowledge of SOPs, GCPs and local/international regulations

  • Demonstrated interpersonal skills

  • Ability to analyze data, share information and make recommendations for improvements

  • Appropriate MS Office skills, EDC, eCRF and possibly IT/SQL skills but not essential

  • Good organizational and planning skills.

  • A strong team player, with excellent organizational and problem solving skills and the ability to work independently. Must be able to multi-task and work well within a high pace pressurized environment

  • Demonstrate the ability to lead team and make decisions.

  • Proficient in decision making, problem-solving, prioritizing, critical thinking and analytical skills

  • Demonstrate the ability to work in a team environment and collaborate with peers

  • Be comfortable interacting at senior /mid Management

  • Excellent communication skills and proven ability to interact with management level

  • Delivers clear and concise instructions and ensures that important information from management is shared with employees and others as appropriate

  • Ensures performance measures are in place to monitor and assess attainment of goals and objectives

  • Anticipates potential challenges, develops plan to overcome then and then carries out the plan

  • Identifies resources needed to accomplish objectives

  • Able to look ahead when addressing work and/or needs

Synexus offers a comprehensive benefits package that includes medical, dental, and vision insurance offerings, life and disability insurance offerings, 401K, paid time off, and various other benefits and discount programs!

Synexus is an Affirmative Action and Equal Opportunity Employer.

Synexus offers a comprehensive benefits package that includes medical, dental, and vision insurance offerings, life and disability insurance offerings, 401K, paid time off, and various other benefits and discount programs!

Synexus is an Affirmative Action and Equal Opportunity Employer.

Salary Competitive Pay Plus Benefits

Job Reference synexus/TP/13884/1547

Job Category Operations - Clinical

Closing Date 2019-01-06

Business Unit Synexus US

Location Chicago, IL, United States