Clinical Data Manager II

🔥 12 hours ago

🇺🇸 United States – Remote

💵 $110.7k - $166.1k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 0%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $75M Private Equity Round on 2015-12

Healthcare • Consulting • Logistics

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

• Manage all aspects of the clinical trial data management process from study start-up to post-database lock for assigned projects under some supervision • Serve as primary Data Management contact or contributor for assigned clinical projects/programs, ensuring continuity, responsiveness, and timely task completion • Perform data entry and quality control for paper-CRF studies as needed • Provide input into timelines, ensure clinical data management deadlines are met with quality, and assess resource needs as needed • Develop CRF specifications from clinical study protocols and coordinate stakeholder review and feedback • Assist in building clinical databases • Conduct database build UAT and maintain quality-controlled database build documentation • Oversee overall clinical database quality • Specify requirements for electronic, manual data review, and other edit checks • Create, revise, version, and maintain data management documentation and oversee Trial Master File completeness • Train clinical research personnel and project team members on study-specific CRFs, EDC, and related items • Review and query clinical trial data according to the Data Management Plan • Perform line-listing data review and patient- and study-level status and metric reporting • Perform medical coding of medical terms to ensure medical logic and consistency • Coordinate SAE/AE reconciliation • Liaise with third-party data and EDC vendors in a project manager capacity • Assist with SAS programming and quality control of SAS programs • Identify and troubleshoot operational problems using metrics data, audit reports, and stakeholder input • Review and provide feedback on protocols, SAPs, and CSRs when required • Participate in developing and maintaining SOPs and process documentation • Attend strategy meetings, bid defense preparation, capability presentations, and potential client engagement meetings as needed • Review RFPs, proposals, and provide project estimates as needed • Communicate with sponsors, vendors, and project teams regarding data, database, and project issues • Present software demonstrations, trainings, and project meetings as needed • Perform other assigned duties

🎯 Requirements

• Bachelor’s degree and/or a combination of related experience • 5+ years’ Clinical Data Management experience or demonstrated aptitude in the key skills for the role • Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook • Able to handle a variety of clinical research tasks • Excellent organizational and communication skills • Must be able to read, write, speak fluently and comprehend the English language • Experience in utilizing a clinical database management system • Broad knowledge of drug, device and/or biologic development and effective data management practices • Ability to undertake occasional travel • Understanding of dictionary medical coding (MedDRA and WHODrug) preferred • Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…) preferred • Oncology therapeutic experience preferred • Candidates must be legally authorized to work in the country of employment without employer sponsorship

🏖️ Benefits

• Discretionary annual bonus • Health insurance • Retirement savings benefits • Life insurance • Disability benefits • Parental leave • Paid time off for sick leave and vacation • Potential occasional travel opportunities

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume