Senior Clinical Data Manager

🕒 March 19

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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. • 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 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. • 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 • 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 • Systems knowledge with Medidata Rave and Veeva • Ability to undertake occasional travel

🏖️ Benefits

• Any data provided as a part of this application will be stored in accordance with our Privacy Policy. • For CA applicants, please also refer to our CA Privacy Notice. • Equal Opportunity Employer