Senior Clinical Data Manager
Senior Clinical Data Manager
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Job Description
Job Title: Senior Clinical Data Manager
Location: Remote (USA / Canada)
Job Overview:
We are seeking skilled and customerfocused Clinical Data Managers to lead manage and perform data processing activities for clinical trials ensuring high data quality and adherence to project timelines. This includes database management quality control and training of junior staff while ensuring compliance with industry standards and protocols.
Key Responsibilities:
- Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s) ensuring that there is backup continuity responsiveness and that tasks are performed in a timely manner. May support another Lead DM as a backup and/or team member. May include DM oversight of sponsor programs.
- Oversee project data entry process including development of data entry guidelines training data entry quality and resourcing
- May perform quality control of data entry
- Provide input assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects as needed.
- Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
- May assist in building clinical databases
- Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
- May specify requirements for all edit check types e.g. electronic manual data review edit checks etc. Oversee development of the edit check specifications and manual data review specifications
- Responsible for creating revising appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.
- Train clinical research personnel on the study specific CRF EDC and other project related items as needed.
- Review and query clinical trial data according to the Data Management Plan
- Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
- Run patient and study level status and metric reporting
- Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
- Coordinate SAE/AE reconciliation
- Liaises with thirdparty vendors such as external data and EDC vendors in a projectmanager capacity in support of timelines and datarelated deliverables
- May assist with SAS programming and quality control of SAS programs used in the Data Management department
- Identify and troubleshoot operational problems issues obstacles and barriers for studies based on metrics data audit reports and input from project team members and other stakeholders
- May assist in reviewing and providing feedback on protocols Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs) if required by the project
- Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
- May attend strategy meetings bid defense prep meetings bid defenses capability presentations potential client engagement meetings
- May review Request for Proposals (RFP) proposals provide project estimates
- Provide leadership for crossfunctional and organizationwide initiatives where applicable
- Trains and ensures that all data management project team members have been sufficiently trained
- Communicate with study sponsors vendors and project teams as needed regarding data database or other relevant project issues
- May present software demonstrations/trainings department/company training sessions present at project meetings
- May require some travel
- Perform other duties as assigned
Qualifications:
- 8 years experience for a Sr. Clinical Data Manager and 10 years for a Principal Clinical Data Manager
- Proficiency in Microsoft Office: Word Excel PowerPoint Outlook
- Able to handle a variety of clinical research tasks
- Excellent organizational and communication skills
- Professional use of the English language; both written and oral
- Experience in utilizing various clinical database management systems
- Broad knowledge of drug device and/or biologic development and effective data management practices
- Strong representational skills ability to communicate effectively orally and in writing
- Strong leadership and interpersonal skills
- Ability to undertake occasional travel
- Experience in a clinical scientific or healthcare discipline
- Dictionary medical coding (MedDRA and WHODrug)
- Understanding of CDISC standards (CDASH SDTM ADaM etc. )
- Oncology and/or Orphan Drug therapeutic experience
Mindtris a minority womenowned enterprise is at the forefront of digital transformation technology excellence and business growth solutions. Specializing in talent mobilization and innovation we are dedicated to enhancing customer experiences across diverse sectors such as Information Technology Telecommunications Healthcare Engineering and the Public sector. With a focus on deploying toptier talent and fostering innovation we empower businesses to thrive and excel in a rapidly evolving digital landscape helping them reach new heights of success. Mindtris is committed to fostering workforce diversity and is proud to be an equal opportunity employer.
Employment Type
Full Time
