Senior Clinical Data Manager

该职位来源于猎聘 This position supports remote work. JOB ACCOUNTABILITIES:

• Lead Data Management Activities; Perform Training and Client Relationship Management 1) Develop and maintain the Data Management Project Plan (Plan). Document deviations from the Plan, log and report issues, and follow-up on their resolutions. 2) Act as the primary contact person for day-to-day data management activities and the person ultimately responsible for all data management deliverables for assigned projects. 3) Act as the primary contact person for communication and discussion of topics related to data management timelines and deliverables; requests for out-of-scope tasks; and the first line contact for technical or procedural issues. 4) Plan and implement data management timelines and deliverables; providing database and data management activities status reports; and contribute to the overall project planning, progress tracking, and reporting. 5) Assist with study-level resource planning and management, including the review of team members’ timesheet reports. 6) Assist in performing client relationship management activities. Participate in project bid defense meeting when required. 7) Perform training on electronic data capture (EDC) system, dataflow, and quality control (QC) processes to clinical trial personnel. 8) 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. 9) Assist in the generation of project Work Orders and Amendments. 10) Assist in the management of dataflow from and performance of third party vendors (non-Case Report Form [CRF] data vendors). 11) Participate in project kick off meetings, investigators meetings, and regular project management team meetings. 12) Provide support with client audits and regulatory inspections. Follow-up on audit findings. 13) Create and maintain clinical trial Data Management Study Binders.
• Perform Hands-on Data Management Activities 1) Design and review CRFs/electronic CRFs. Develop and review CRF Completion Instructions. Generate and review annotated CRFs. 2) Design and review Clinical Trial Source Document templates and completion instructions when required. 3) Develop and maintain the Data Validation Specifications. 4) Develop and maintain the Data Management Plan (DMP). Document deviations from the DMP. 5) Participate in the database design process. Participate in EDC User Acceptance Testing. 6) Manage the process of database modifications (after go-live) due to protocol amendments or study needs. 7) Develop and maintain the 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. 8) Perform third-party non-CRF data management activities. 9) Review data; issue and resolve queries. Assist investigative site personnel with resolving queries. 10) Perform serious adverse event reconciliation. 11) Assist in resolving medical coding discrepancies resulting from the coding of medical history, adverse events, procedures, and medicinal products. 12) Cooperate with and assist the Quality Assurance department with QC audits on assigned databases. 13) Perform database soft-lock and hard-lock activities. 14) 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 MAJOR DECISIONS WITHIN THE INCUMBENT’S AUTHORITY LEVEL: The incumbent may make decisions in the following areas:
• Time allocation to complete assigned projects.
• Completeness, accuracy, and efficiency of products.
• Schedule of training/education for professional development. DECISIONS REFERRED TO THE NEXT LEVEL OF MANAGEMENT: The incumbent may, in consultation with the direct manager and other relevant functional group leaders, make recommendations on the following decisions. However, the final decision/signing authority in each of the following areas will be with the corporate designated signing officers.
• Priorities of projects.
• Allocation of resources to projects.
• Development and implementation of clinical data standards, methods, and technologies.
• Professional development. LEVEL OF ACCOUNTABILITY: The effectiveness and efficiency of performance of this position has a direct bearing on the smooth operation of Everest Clinical Data Management projects. Effective job performance can have a major impact on the clients’ confidence in Everest’s capabilities. The position will impact approximately 3-6 projects being conducted at any given point in time. KEY EQUIPMENT/SOFTWARE USED:
• Microsoft Word, Excel, PowerPoint, Outlook, Teams.
• Oracle InForm.
• Medidata Rave.
• DFdiscover.
• CTMS.
• JReview.
• Other software as may be required. KEY JOB COMPETENCIES:
• Action Oriented: Enjoys working hard; is action oriented and full of energy for the things he/she sees as challenging; not fearful of acting with a minimum of planning; seizes more opportunities than others.
• Customer Focus: Is dedicated to meeting the expectations and requirements of internal and external customers; gets first-hand customer information and uses it for improvements in products and services; acts with customers in mind; establishes and maintains effective relationships with customers and gains their trust and respect.
• Functional and Technical Skills: Has the functional and technical knowledge and skills to do the job at a high level of accomplishment.
• Informing: Provides the information people need to know to do their jobs and to feel good about being a member of the team, unit, and/or the organization; provides information to individuals so that they can make accurate decisions; is timely with information.
• Integrity and Trust: Is widely trusted; is seen as a direct, truthful individual; can present the unvarnished truth in an appropriate and helpful manner; keeps confidences; admits mistakes; does not misrepresent him/herself for personal gain.
• Listening: Practices attentive and active listening; has the patience to hear people out; can accurately restate the opinions of others even when he/she disagrees.
• Patience: Is tolerant with people and processes; listens and checks before acting; tries to understand the people and the data before making judgments and acting; waits for others to catch up before acting; is sensitive to due process and proper pacing; follows established process.
• Peer Relationships: Being able to quickly find common ground and solve problems for the good of all; being able to represent his/her own interests and yet be fair to other groups; being able to solve problems with peers with a minimum of noise; being seen as a team player and is cooperative; easily gaining trust and support of peers; encouraging collaboration; being able to be candid with peers.
• Perseverance: Pursues everything with energy, drive, and a need to finish; seldom gives up before finishing, especially in the face of resistance or setbacks.
• Written Communications: Is able to write clearly and succinctly in a variety of communication settings and styles; can get messages across that have the desired effect. QUALIFICATIONS:
• 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 years 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.
• Demonstrate an in-depth understanding of clinical trial data management concepts, processes and procedures, and relevant issues related to or impacting clinical data management, as well as pharmaceutical clinical trial regulations, industry guidance, conventions, and standards.