Job Description :
Role: Clinical Data Manager / Data Team Lead / Senior Data Team Lead (3 Different position)
Location: Durham, NC (REMOTE)
Duration: Long term contract
Visa: H4-EAD, GC-EAD, L2-EAD, GC and USC
Note: Candidate must have Lead exp
PURPOSE:
Manage end-to-end delivery of data management services for single/multi-service projects, 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 and vision to the team in the areas of project planning, execution, and close-out; financial management; communications; and milestone deliverables. May perform role of Data Team Lead (DTL), Program Lead, and/or a leadership role in a specific CDM task (e.g. Subject Matter Expert (SME Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents
JOB DESCRIPTION:
Participate in and support RFP process (review RFP documents, pricing, attend bid defense)
Other:
Independently bring solutions to the CDM team/CDM department
Lead and/or participate in a focus team or global or local best practice team
Communicate lessons learned and/or present in CDM workshop(s)
Participate in the development and implementation of new technology or tool
Present at professional conferences and/or publish articles in professional journals
Provide review and input on developing, revising, and maintaining core operating procedures and work instructions
Perform other duties as directed by the functional manager
RESPONSIBILITIES:
Client Management:
Serve as primary point of contact for customer on data management deliverables
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
Provide justification for and perform direct negotiations with customer, e.g., timelines, financial, process, resources
Maintain strong customer relationships
Maintain the Data Management study files in the audit ready condition.
Ensure open communications with customer and management to manage and meet contractual obligations
Service Management:
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
Support DM service delivery with comprehensive DM process and technical expertise in executing projects
Serve as the escalation point for unresolved data issues; 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
Create and/or review and sign-off on all data management plan (DMP) documents
Ensure service and quality meet agreed upon specifications per the DMP and contract/SOW
Implement proactive quality management plans across multiple projects/programme. Track service performance and provide leadership to identify root causes of issues and implement remedial actions
Continuously look for opportunities to improve service; work with team to develop and implement plan to re-organise and drive change across multiple projects/programme (with minimal support)
Ensure timely follow-up and resolution of compliance issues
Serve as Subject Matter Expert (SME)
Provide leadership and expertise in a specific CDM task or technology
Train and mentor junior DTL staff in DM expertise. May coordinate the work of more junior DTL staff
Maintain internal tracking databases and systems
Financial Management/Business Development Support:
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
Serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing
Independently bring solutions to the CDM team/CDM department
Lead and/or participate in a focus team or global or local standard methodology team
Communicate lessons learned and/or present in CDM workshop(s)
Participate in the development and implementation of new technology or tool
Present at professional conferences and/or publish articles in professional journals
Perform other duties as directed by the functional manager
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:
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 GCP and relevant regulatory guidelines
Excellent communication, interpersonal, customer service, and teamwork skills
Excellent project management skills
Excellent organizational and analytical skills
Comprehensive understanding of clinical drug development process
Demonstrated extensive data management skills and thorough knowledge of the data management process (e.g., therapeutic area, deep understanding in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology)
Required Education and Experience:
Bachelor's Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related discipline, and 8 years direct Data Management experience, including 3 to 5 or more years as a CDM project lead; or equivalent combination of education, training and experience
Previous experience and shown competence in leading delivery of multiple projects through full DM life-cycle (several studies/programmes)
Previous experience of handling customer negotiations
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 GCP and relevant regulatory guidelines
Excellent communication, interpersonal, customer service, and teamwork skills
Excellent project management skills
Excellent organizational and analytical skills
Comprehensive understanding of clinical drug development process
Thanks
Kartheek.G
karthikg(at)softpathtech(dot)com