Lead Clinical Data Manager

Integrated Resources, Inc

Lexington, Massachusetts

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JOB DETAILS

JOB TYPE

Contractor

SKILLS

Analysis Skills, Bid Analysis, Biostatistics, Budget Forecasting, Budget Management, Budgeting, Calendar Management, Clinical Data Interchange Standards Consortium (CDISC), Clinical Data Management, Clinical Research, Clinical Trial, Communication Skills, Consulting, Contract Management, Contract Research Organization (CRO), Cost Benefit Analysis, Cost Forecasting, Customer Relations, Data Management, Decision Support, Detail Oriented, Documentation, Drug Development, Establish Priorities, Forecasting, GCP (Good Clinical Practices), Health Information Management, ICH Regulations, Identify Issues, Information Technology & Information Systems, Leadership, Mentoring, Microsoft Access Database, Microsoft Excel, Microsoft Outlook, Microsoft PowerPoint, Microsoft Word, Multitasking, Organizational Skills, Performance Management, Performance Metrics, Presentation/Verbal Skills, Problem Solving Skills, Process Improvement, Project/Program Management, Proofreading, Quality Metrics, Regulations, Rehabilitation Nursing, Reporting Skills, Request for Proposals (RFP), Schedule Development, Standard Operating Procedures (SOP), Statements on Auditing Standards (SAS), Statistical Analysis System (SAS), Statistical Programming Languages, Status Reports, Strategic Planning, Team Lead/Manager, Team Player, Technical Writing, Testing, Time Management, Vendor/Supplier Evaluation

LOCATION

Lexington, Massachusetts

POSTED

Today

Lead Clinical Data ManagerA Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.Job DescriptionThe Clinical Data Manager will have a demonstrated ability to oversee the data management activities across a single clinical program or group of related studies. Provides Data Management leadership and expertise to project and study teams. Will have a good knowledge of the end to end clinical research and data management processes, as well as global regulatory and industry rules and guidance (i.e. ICH, GCP) to support drug development processes and global project submissions through to approval.Responsibilities:Responsibilities for managing data management components of project and study budgets and vendor performance.May mentor team members and more junior staff and may direct activities of contract Data Manager staffJob Function and Description Delivering Excellence:· Takes leadership role in project implementation as a member of the clinical study or project team, ensures oversight of the Data Management CRO.· Provides status reports/updates, resolves disputes, and ensures timely acquisition of high quality deliverables from the CRO Provides Data Management expertise to the team in identifying opportunities for process and budgetary optimization Coordinates with Biostatistics and Statistical Programming to ensure appropriate design, documentation, testing and implementation of SAS data deliverables according to internal and regulatory standards Works with team members via matrix relationships (internally or at CROs) by directing work, resolving problems and/or providing guidanceAccountability and Ownership:· Drives accountability at every possible level Ensures Data Management CROs are delivering quality data and documentation on time, on budget and to Clients quality standards and SOPs Reviews Data Management CRO performance measures and evaluates cost/benefit of actions taken to remedy or improve performance Collaborates with CRO and study team members to identify and resolve issues impacting goal attainment.Judgment and Decision Making:· Evaluates immediate business impact and takes decisive action Provides within and between study comparisons of DM timelines for assigned projects.· Takes action to ensure study and project priorities are maintained; ensures adjustment of plans as priorities evolve Contributes to regular budget forecasting and regular cost accrual processes and proactively communicates to the team budgetary impacts of decisions or processes implemented to achieve results Courage to challenge· Takes risks and challenges norms to support tomorrow's needs Supports consistent implementation of globally agreed study delivery and clinical development strategies including process and technology related to DM Operations Serving Customers· Partnering with customers as a trusted consultant and becoming an integral part of customer's decision making Supports each clinical study and project team by ensuring data management plans and data handling activities are designed to meet project and protocol deadlines.· Consults with the team(s) to ensure the teams long-term needs are addressed.· As Data Management lead to the clinical study, becomes involved in decision making processes to ensure maximum performance of the team. Provides Data Management expertise to the teams in customer oriented point of view Leads development of Data Review Plans· Contributes to other key study level documents (e.g. protocols, SAPs)Building Authentic Relationships· Building trusting relationships that will enhance current and future needs Leads in developing trust through transparency in communication and individual actions· Ensures outcomes are team driven rather than individually driven· Promotes collaborative team and organizational success Key Skills, Abilities, and Competencies· Must be able to produce data management reports Strong attention to detail and accuracy is a must. Ability to read, analyze and interpret complex technical documents.· Ability to present complex issues in oral and written form.· Strong knowledge of MS Word, Excel, PowerPoint, Access and Outlook.· Must be able to independently present complex information to departmental management, professional organizations, CROs and the medical community.· Proven ability to manage and communicate effectively with research vendors including reviewing request for proposals, analyzing scope of work, budgeting and forecasting, responding to inquiries and complaints. Demonstrated ability to prioritize across work assignments.· Proven ability to independently resolve problems.· Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines.· Must be able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands.· Ability to work independently, take initiative and complete tasks to deadlines.· Understanding and facility with CDISC/CDASH standards Demonstrated knowledge of data management and drug development process May be responsible for supervising Clinical Data Management contractors.Qualifications· B.S. degree in Scientific or related field is preferred.· Minimum of 5-7 years as a Senior Data Manager within a Data Management organization Experience with leading teams and/or organizations.· CCDM certification preferred

Lead Clinical Data Manager

Integrated Resources, Inc

Lexington, Massachusetts

About the Company

Integrated Resources, Inc

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