Clinical Data Manager Job Category: Clinical Data Management Requisition Number: CLINI002640 - Full-Time - Locations Markham, ON L3R0B8, CAN Remote Canada To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Clinical Data Managers for our Toronto/Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy. Key Accountabilities: - Plan, manage, control, and perform data processing and management activities for assigned projects. These tasks are performed in a timely and accurate manner and in compliance with trial Sponsors’ requirements. - Lead assigned data processing and management projects by applying project management skills, data processing, and management techniques. Manage timelines and coordinate activities for assigned projects. - Specify database validation checks for assigned studies. Lead efforts in developing and maintaining standard database validation checks for common modules as well as for therapeutic/drug area specific modules. - Define and monitor clinical trial dataflow and quality control (QC) processes in accordance to corporate Standard Operating Procedures (SOPs), Good Working Practices, and unit guidelines. Perform clinical trial site monitors’ training on dataflow and QC processes. - Design and review patient Case Report Forms (CRFs) and database schema. Test data capture/entry screens. - Accurately and efficiently validate electronically captured data. Write clear queries on missing data and data points failing pre-defined range checks and/or logical checks. Lead efforts in building a standard query library for common database modules, as well as for therapeutic/drug area specific modules. - Perform QC procedures on assigned database during the trial and additional database closure checks at the end of the study. - Train and supervise Data Entry personnel and junior data management personnel on study procedures, study specific handling, and management of trial data. - Validate and distribute study progress status reports to internal and external study team members. - Assist in resolving data coding discrepancies resulting from the coding of medical events, treatment procedures, and medications. - Maintain and prepare for final archival of data management documentation relevant to the assigned clinical trials and assist the corporate archivist in assembling and archiving clinical trial data and study documentation. - Cooperate with and assist, when required, data management quality assurance (QA) personnel in performing QA procedures on trial CRFs, database schema, and databases for assigned studies. Qualifications and Experience: - A Bachelors’ degree in health and/or pharmaceutical sciences, physical/biological, or chemistry fields with at least 2 years experience in clinical trial data capture and management, or a Master’s or Ph.D degree in these fields with at least 1 year relevant experience. - In-depth understanding of clinical trial data management concepts, processes and procedures, relevant issues related to or impacting clinical data management, as well as pharmaceutical clinical trial regulations, industry guidance, conventions and standards. - Strong leadership in clinical data management activities and a desire to excel in leading data management projects. Benefits & Compensation: We offer a robust benefits package to support your health, well-being, and growth, including medical, dental, and vision coverage, life & AD&D insurance, short- and long-term disability, tuition reimbursement, fitness reimbursement, employee assistance program (EAP), a pension plan, generous paid time off and sick leave, and the opportunity to earn a performance based bonus. Estimated Salary Range: $60,000 - $90,000. #LI-Remote

Senior Clinical Data Manager Job Category: Clinical Data Management Requisition Number: SENIO002639 Full-Time Locations Bridgewater, NJ 08807, USA Remote United States Job Details Description To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Senior Clinical Data Managers for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA in accordance with our Work from Home policy. Key Accountabilities: Lead Data Management Activities, Perform Training and Client Relationship Management - Develop and maintain Data Management Project Plan (Plan). Document deviations from the Plan, log and report issues, and follow up on their resolutions. - Is the primary contact person for day to day data management activities, and is the person ultimately responsible for all data management deliverables for assigned projects. - Is the primary contact person for communication and discussion of topics related to data management timelines and deliverables; request for out of scope tasks; first line contact for technical or procedural issues. - Is responsible for planning and implementing data management timelines and deliverables; and is responsible for providing database and data management activities status reports; contributes to the overall project planning, progress tracking and reporting. - Assist with study-level resource planning and management, including the review of team members’ timesheet reports. - Assist in performing client relationship management activities. Participate in project bid defense meeting when required. - Perform training on electronic data capture (EDC) system, dataflow and quality control processes to clinical trial personnel. - Provide training to new data management personnel on data management processes and procedures. Perform QC review of work performed by less experienced data management personnel. - Assist in generation of project Work Orders and Amendments. - Assist in management of dataflow from and performance of Third Party Vendors (Non-CRF data vendors). - Participate in project kick off meeting, investigators meeting, and regular project management team meeting. - Provide support to client audits and regulatory inspections. Follow up on audit findings. - Create and maintain clinical trial Data Management Study Binders. Perform Hands-on Data Management Activities - Design and review case report forms (CRFs/eCRFs). Develop and review Case Report Form Completion Instructions. Generate and review annotated Case Report Forms. - Design and review Clinical Trial Source Document templates and completion instructions when required. - Develop and maintain data validation specifications. - Develop and maintain Data Management Plan (DMP). Document deviations from the DMP. - Participate in the database design process. Participate in EDC User Acceptance Testing (UAT). - Manage the process of database modifications (after go-live) due to protocol amendments or study needs. - Develop and maintain Data Quality Review Plan (DQRP). Coordinate with programmers to complete the programming and validation of the listings and summary tables as specified in the DQRP. - Perform Third Party non-CRF data management activities. - Review data, issue and resolve queries. Assist Investigative Site personnel with resolving queries. - Perform Serious Adverse Event reconciliation. - Assist in resolving medical coding discrepancies resulting from coding of medical history, adverse events, procedures and medicinal products. - Cooperate and assist the Quality Assurance Department with quality control audits on assigned databases. - Perform database soft-lock and hard lock activities. - Maintain and prepare final archival of data management documentation relevant to the assigned clinical trials, and assist the corporate archivist in assembling and archiving such documentation. Qualifications and Experience: - A Bachelors’ or Master’s degree in health and/or pharmaceutical sciences, physical/biological, or chemistry fields. - At least 5 years of experience in pharmaceutical clinical trial data management or at least 2 year of experience as a Clinical Data Manager II, with demonstrated knowledge, experience and ability to perform to meet high quality standards and high level of customer satisfaction. - Demonstrated an in-depth understanding of clinical trial data management concepts, processes and procedures, relevant issues related to or impacting clinical data management, as well as pharmaceutical clinical trial regulations, industry guidance, conventions and standards - Demonstrated a strong leadership in clinical data management activities and a desire to excel in leading data management projects. Benefits & Compensation: We offer a robust benefits package to support your health, well-being, and growth, including medical, dental, and vision coverage, life & AD&D insurance, short- and long-term disability, tuition reimbursement, fitness reimbursement, employee assistance program (EAP), a 401(k) retirement / pension plan, generous paid time off and sick leave, and the opportunity to earn a performance based bonus. Estimated Salary Range: $90,000 - $130,000.

Assess and implement personalized care plans for members, coordinate with healthcare providers, monitor progress towards goals, and educate members and families on available services to ensure high-quality care outcomes.

Role Description The Area Manufacturing Manager (AMM) acts as a consultant to provide high level manufacturing expertise in the application of best available technology and practices across all 10 PCA mills with a focus on Gas Turbines and HRSGs. The AMM works with mill manufacturing and corporate resources to facilitate the exchange of best practices between mills. Relocation not required – must be willing to travel 80%. - Responsible for the reliability and operations of the gas turbines and HRSGs. - Lead, teach, and develop mill plans for the mill operations of the gas turbines and HRSGs. - Implement strategies to improve gas turbine operations efficiencies. - Analyze current Capital and Assets to determine immediate needs as well as plans for predicted future needs. - Craft Capital Allocation Requests for financial and investment review and implementation. - Ensure project plans are updated frequently with deadlines that reflect current conditions and anticipated completion timelines. - Track spending within CAR implementation to ensure costs allocated correctly and anticipated ROI is achieved. - Analyze data and reports to identify opportunities for improvement in key metrics such as throughput, yield, R&A. - Develop project and work plans to address identified improvement opportunities and achieve Company goals. - Analyze processes, procedures, and machine efficiency to drive continuous improvement. - Recommend equipment upgrades or changes to meet industry trends and customer demands. - Support the development of the CAR to secure required Capital. - Direct and oversee the work of 1-10 Process Optimization Engineers within the Area of responsibility. - Coordinate a wide range of projects from simple to extremely complex within facilities in the Area and manage the necessary resources for the completion of the project. - Develop project plans and communicate the status with key stakeholders. - Identify key workflows and product flows and allocations that enable the Area to better meet the needs of customers while also meeting operational goals and objectives. - Provide guidance and knowledge to Plant Management to aid in decision making. - Ensure plans to maintain and upkeep assets and equipment are executed within each location. - Know and follow policies and procedures of the company, share information that would benefit other members of the team, and find ways to improve the delivery of service to our customers. - Strive to continually strengthen PCA’s business philosophy of meeting needs and exceeding expectations for customers specifically supporting PCA’s Commitment to Service. Qualifications - High School Diploma or GED education equivalent is required. - Ten (10) years’ previous experience in Corrugated Operations. - Advanced knowledge of equipment within Packaging Manufacturing required; corrugated and finishing experience. - Gas turbine experience is highly recommended; Siemens 251 experience is a plus. - Both operations and maintenance experience is required. - Solid working knowledge of processes and components related to the manufacture of Corrugated products. - Experience with manufacturing safety practices. - Solid analytical, mechanical, and communication skills. - Ability to critically write technical documents including CARs. - Working knowledge of manufacturing systems including shop floor and BPMS software. - Organizational skills with the ability to manage numerous details, deadlines, and requests. - Ability to work in a fast-paced, deadline-oriented environment, prioritize assignments, and oversee multiple projects and/or requests concurrently. - Previous work experience as a member of a team, or a strong understanding of the importance of open communication and information sharing between team members. - Ability to give directions to internal and external customers and vendors or suppliers to ensure project completion in a timely and efficient manner. - Able to frequently travel to facilities for assessments, support, and projects. - Able to work flexible hours as needed. Benefits - Starting salary range for position: $129,500-$185,000. - Bonus: Annual – Based upon individual contribution and overall Company performance. - Paid Vacation: Three (3) weeks per calendar year. Pro-rata Vacation during the initial year of hire based upon start date within the calendar year. - Paid Holidays. - Within the first 30 days of employment, an employee (and their dependents) is eligible to enroll in certain benefit coverages -- medical, dental, and vision – and are automatically enrolled in life, AD&D, and disability coverages. - Upon hire, an employee is automatically enrolled in the 401k plan. The plan offers both pre-tax and Roth contribution options along with employer provided matching contributions. Company Description PCA is an Equal Opportunity Employer. Qualified Applicants must apply at careers.packagingcorp.com to be considered.