Clinical Data Manager II / Senior Clinical Data Manager

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Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $75M Private Equity Round on 2015-12

Biotechnology • Healthcare Insurance • Pharmaceuticals

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 Description

• Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up 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. • May develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders • 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 third-party vendors such as external data and EDC vendors in a project manager capacity in support of timelines and data-related 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 cross-functional and organization-wide 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

🎯 Requirements

• Bachelors and/or a combination of related experience • 8+ years’ experience as a Sr. Clinical Data Manager or 5+ Years as a Clinical Data Manager II working for a Clinical Research Organisation, Pharmaceutical or Biotech company • Set up and Database migrations experience • Oncology experience preferred • Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook • 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

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Professional development opportunities