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

• Responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. • Oversee and/or perform database development and testing. • Ensure 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. • Ensure that clinical data management deadlines are met with quality. • 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. • Responsible for creating, revising, appropriate versioning and maintaining data management documentation. • Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed. • Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM. • 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.

🎯 Requirements

• Bachelors and/or a combination of related experience • Ability to communicate both verbally and in writing at the English proficiently (Professional level) • 8+ years’ experience OR Combination of qualifications and equivalent relevant experience may be accepted as an alternative. • 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

• Employee health insurance • Paid time off • Professional development opportunities