*** * Ascent Life Sciences is seeking a?REMOTE lead CDM?for a?contract to hire opportunity.? Apply by clicking the link below for immediate consideration or reach Alicia Licht at with questions or for more information * * **
Manage end-to-end delivery of data management services for single/multi-service projects with minimal guidance, ensuring quality deliverables on time and within budget, to customer satisfaction.
Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs.
Provide leadership to the team in the areas of project planning, execution, and close-out; financial management; communications; and milestone deliverables.
Perform role of Data Team Lead (DTL). Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.
Serve as primary point of contact for customer on data management deliverables
With minimal guidance, provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise
With guidance, provide input for and perform direct negotiations with customer, e.g., timelines, financial, process, resources
Maintain strong customer relationships
Ensure open communications with customer and * * * management to manage and meet contractual obligations
Meet with Data Operations Coordinator (DOC) and/or Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables
Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders
With minimal guidance, support DM service delivery with comprehensive DM process and technical expertise in executing projects
Serve as the escalation point for unresolved data issues; with guidance, work with client data managers, vendors, internal team members for resolution
Work with functional manager(s) to ensure appropriate resources are assigned to meet project deliverables
With guidance, create and/or review and sign-off on all data management plan (DMP) documents
Implement proactive quality management plan. Identify any service and quality issues with agreed upon specifications per the DMP and contract/SOW and work with functional manager(s) to resolve
With guidance, track service performance and provide leadership to identify root causes of issues and implement remedial actions
Continuously look for opportunities to improve efficiency of tasks and quality of deliverables
Identify compliance issues and work with functional manager(s) to ensure timely follow-up and resolution
With guidance, maintain internal tracking databases and systems
FINANCIAL MANAGEMENT/BUSINESS DEVELOPMENT SUPPORT
With guidance, ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work (SOW)
Manage SOW/budget-Review financial reports on a monthly basis and participate in project reviews as requested-Identify out of scope tasks and track change orders to completion
With guidance, may serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing
With guidance, participate in and support RFP process (review RFP documents, pricing, attend bid defense)
Provide input on DM process improvements or project solutions to CDM team/CDM department
Provide input on the development and implementation of a new technology or tool
Participate in a focus team or global or local best practice team
Perform other duties as directed by functional manager(s)
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Previous experience and proven competence in managing study delivery through full DM life-cycle (at least 1 medium Phase III)
Demonstrated data management skills and thorough knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology)
Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology
Knowledge of operating procedures and work instructions and the ability to apply them in practice
Knowledge of Good Clinical Practices and applicable regulatory guidelines
Excellent communication, interpersonal, customer service, and teamwork skills
Excellent organizational and problem-solving skills
Excellent project management skills
Ability to work with minimal supervision, using available resources, e.g., functional managers, senior DTLs
Comprehensive understanding of clinical drug development process
Ability to establish and maintain effective working relationships with coworkers, managers and customers
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Extensive use of telephone and face-to-face communication requiring accurate perception of speech
Extensive use of keyboard requiring repetitive motion of fingers
Regular sitting for extended periods of time
Occasional travel is required
Ascent is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. Ascent's fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Ascent works as both a reliable supplier in support of programs, as well as a Strategic Advisor in support of enterprise efforts to establish best in class preferred vendor programs. Ascent was ranked in the 2007 and 2008 Inc. 500 and recognized specifically for its innovative work in staff augmentation support of Large Enterprise preferred vendor accounts.
If you are ready to propel your career to new heights… read on. We are looking for talented and dedicated colleagues to join our phenomenal team. At Ascent, we have created an environment where culture, commitment and opportunity converge to yield a truly unique place to work. We know that every employee has something important to say and that every employee is integral to our success. Where else can you walk over to a founder and talk about your ideas to help build our business and have that idea implemented in 48 hours? More importantly, we do everything we can to make sure our employees not only have great jobs, but great lives.