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Medical Records Jobs in Massachusetts

Senior Clinical Document Management Specialist

Integrated Resources, Inc

Lexington, Massachusetts

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JOB DETAILS
JOB TYPE
Contractor
SKILLS
Best Practices, Biotech and Pharmaceutical, Calendar Management, Clinical Data Management, Clinical Practices/Protocols, Clinical Research, Clinical Study Publications, Clinical Support, Clinical Trial, Clinical Trial Management, Communication Skills, Computer Skills, Contract Research Organization (CRO), Corporate Compliance, Cross-Functional, Customer Relations, Data Management, Detail Oriented, Document Management, Documentation, Driver's License, Establish Priorities, External Audit, FDA (Food and Drug Administration), GCP (Good Clinical Practices), Healthcare Quality, ICH Regulations, Information Technology & Information Systems, Internal Audit, Maintain Compliance, Medical Records, Mentoring, Multitasking, Organizational Skills, Outsourcing, Passport Requirements, People Management, Problem Solving Skills, Records Management, Regulations, Regulatory Requirements, Regulatory Submissions, Rehabilitation Nursing, Research & Development (R&D), Schedule Development, Standard Operating Procedures (SOP), Startup, Team Lead/Manager, Time Management, Willing to Travel
LOCATION
Lexington, Massachusetts
POSTED
Today
Senior Clinical Document Management SpecialistIntegrated 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 DescriptionJob Title: Senior Clinical Document Management SpecialistLocation: Lexington, MA Duration: 12+ months (possibility of extension) PRIMARY DUTIES Reporting to the Clinical Documentation Team Lead, and working in collaboration with the clinical study teams, the Senior Clinical Document Management Specialist is responsible for the management and oversight of Trial Master File (TMF) records from set-up through to final archival of the clinical trial, ensuring compliance with company SOPs and processes, and all applicable regulations. Focusing on inspection readiness, monitors compliance of the TMF and is responsible for preparation of documentation required for regulatory agency inspection and internal audits. Oversees set-up and consolidation of outsourced elements of the TMF with preferred CRO vendors. With support from the management team, performs periodic quality assessments of clinical TMF documents where required. Responsible for delivering assigned Clinical Document Management (CDM) initiatives. Mentors CDM staff on document management process.DUTIES/RESPONSIBILITIES:Managing studies from start-up to close outWorking with CRO's for a large number of studiesEntire lifecycle management of TMFResolving findings and communicating it to the right peopleSenior staffs mentor the regular CDM staff and oversees day-to-day processesInvolved in internal audits and external inspectionsMake sure that they know the location of all the documentsArchive Corporation of documentsQUALIFICATIONS:Someone with management/mentoring responsibility in the past- a very strong nice to haveMin. of 5 yrs. Pharmaceutical experience- doesn't necessarily need to be exclusive to TMF/ CDM experience- must haveDirect experience (in-depth) with TMF related roles- must haveClinical Document Management experienceExperience with clinical trial can be consideredCan consider candidates with lots of years of experience in a clinical setting as long as they have in-depth TMF experienceExperience working with electronic TMF- nice to haveMinimum 5 years of pharmaceutical industry experience related to clinical document managementFamiliarity with various aspects of clinical trials and regulatory submissions, as well as strong knowledge of document management best practices.Current awareness of regulatory requirements for clinical trials (ICH/GCP, FDA, EU Directive).Bachelor's degree or equivalent preferredKEY SKILLS, ABILITIES, AND COMPETENCIES • Sufficient knowledge of regulatory requirements and ICH/GCP guidelines to support clinical records management • Demonstrated ability to work independently, take initiative, complete tasks to deadlines • Requires strong attention to detail, document organization skills, establishing priorities, scheduling and meeting deadlines • Solid communication skills and strong customer focus with ability to interact in a global, cross-functional organization • Ability to communicate effectively with external vendors, including issue escalation, training and responding to inquiries and concerns • Must be able to work in a fast-paced environment with demonstrated ability to prioritize multiple competing tasks and demands • Experience mentoring other members of staff preferred • Experience with use of Electronic Data Management Systems • Advanced computer proficiency • Demonstrated ability to be flexible and to adapt quickly to change Complexity and Problem Solving • Ability to multi-task Internal and External Contacts • Internal study team members within the R&D organization at various levels, global team colleagues; external vendors (CROs, other service providers) Other Job Requirements • Full driving license and passport required • Domestic (within country) and some potential international travel required

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