Job title: Principal Project Data Manager
Company: inVentiv Health Clinical SRE, LLC
Job description: Job Description : Principal Project Data Manager Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to wo
Job Description : Principal Project Data Manager Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of. As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors. Why Syneos Health . #SyneosHealthLife means we’re committed to our Total Self culture – where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference. . We believe our success is a direct result of the people who are driving it – you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health – physical, mental and financial. . 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 On a stand-alone project acts as Project Leader, including primary Sponsor contact for all contracted Data Management activities and deliverables. On a full service project acts as Functional Lead for Data Management including primary contact for internal liaison between Data Management/Operations and Project Management, Clinical Monitoring, and other functional groups May take on a primary oversight/liaison role for a program/partnership including representation on governance committees and input to the Partnership Operating Manual (POM) Development and adherence to standards across a program of projects Coordinate the work of the assigned Data Management/Data Operations team including PDMs assigned to projects within the program Ensures launch, delivery and completion of all Data Management activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations Provides project specific training to internal and external audiences as required Responsible for financial management of assigned projects / programs, including revenue recognition, changes in scope and participation in internal project review meetings, including liaison with Finance and Contracts groups as needed Monitors and communicates project/program progress to the Sponsor and project team including use of project status reports and tracking tools/metrics to enable in stream data collection and query management Supports the management of resources on assigned projects/programs Plans, manages and requests resources for assigned projects / programs supporting PDMs on a program to plan for most efficient resource assignment Develops and maintains project plans, specifications and documentation in line with SOP requirements Maintains documentation on an ongoing basis and ensures that all TMF filing is correct and up to date Participates in, and presents at internal, Sponsor, third-party, and investigator meetings Plans for and creates necessary documentation to support internal and external audits participates in such audits May participate in or lead Data Management/Operations process improvement initiatives May supervise/line manage others Participates in the development of departmental technologies, SOPs, processes, and procedures Trains and mentors data management staff, acts as a subject matter expert. Develops and delivers applicable data management departmental training. Prepares input for, and participates in proposal bid defense meetings Maintains proficiency in Data Management systems and processes through regular training. May attend/represent the company at professional meetings/conferences. Takes the opportunity to network with colleagues for new and/or repeat business May represent Data Management/Data Operations in company-wide initiatives Performs other work related duties as assigned. Minimal travel may be required (up to 25%) Qualifications What we’re looking for Progressively responsible work experience in line with the expectations of the role. Should have 9+ years of experience in Data Management. Must have end to end DM activities experience (Startup, Conduct & Closeout), Strong project Management skills BA/BS in the biological sciences or related disciplines in the natural science/health care field or Registered Nurse. In lieu of degree, equivalent relevant work experience. Extensive Clinical data management experience or an equivalent combination of education and experience. Extensive experience in Clinical Data Management practices and relational database management software systems. Strong project management skills and knowledge of project management methodologies Demonstrated staff leadership skills. Contract Research Organization (CRO) experience preferred. Direct exposure to Oracle Clinical, Rave, or Inform systems. Knowledge of medical terminology, clinical data, and ICH/Good Clinical Practices. Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications. Effective oral and written communication skills. Strong presentation skills Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail. Ability to be flexible and adapt to change, to work independently, as well as part of a multi-disciplinary team. Ability to make effective decisions and manage multiple priorities in a highly dynamic environment. Extensive knowledge of ICH/GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Management
Location: Pune, Maharashtra
Job date: Wed, 16 Jun 2021 22:49:24 GMT
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