Principal/Lead Clinical Data Manager remote

  • Anywhere

Company :
Precision for Medicine

Location :
Princeton, New Jersey

Expiry Date :
Wed, 07 Apr 2021 23:59:59 GMT

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Description :
Why should you considering joining us? Because Precision for Medicine is not your typical CRO. As a member of our thriving team, opportunities to work with leading subject matter experts who understand the rare disease patient mindset and experience will surround you. We help translate science into success for rare disease patients with a targeted, patient-centric approach over a wide geographic area. We are specialists who take on unusual problems in our detailed approach throughout every phase. From the beginning, we have nurtured a culture where patients needs and the needs of our valued clients come first. We focus in an environment where the quality of our work is the best, and where our employees can thrive, while still having fun and giving back to the patient community. We welcome your voice and opinions and provide you with the ability to truly make an impact on drug development. Are you ready to be part of a close-knit clinical trial team that is passionate about saving the lives of patients every single day? Then look no further, we d like to help you take your career to the next level. If the duties below sound like a fit, we d love to hear fro you! Enough about us, let’s hear more about you. About_You * You will manage all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. * You are passionate about deep data analysis and eagerly seek out data anomalies * You have a strong technical aptitude for EDC and database design in oncology & rare disease clinical trials * You are an operational executor driving timeline achievement for all critical data management deliverables * You are a subject matter authority, core team member and sponsor champion * You are adept at direct and open communications across all operational functions and with the sponsor * You love having a key role in an organization where you deliver high quality data management services and where your contributions are recognized and valued * You are on top of your game when it comes to providing study metrics, identifying outliers and mitigating risk * Data quality is your guiding principle * You are passionate about overseeing a team and performing database development and testing. * You are passionate about improving the lives of cancer patients. Here_Are_a_Few_Essential_Day-to-day_Duties * Managing clinical trials through review, computerization, cleaning and auditing of clinical data and databases * Providing input, assessing and managing timelines * Key member of the clinical project team to prioritize project management decisions * Ensuring oversight of data management of the study budget, reuslting in project remaining in cope * Performing line listing data review based on the guidance provided by the sponsor and/or Lead DM * Developing CRF specifications and design * Coordinating SAE/AE reconciliation * Querying data inconsistencies * Patient and Study Level Status/Metric reporting * Performing User Acceptance Testing and overseeing overall quality of clinical database * Participating in the development and maintenance of Standard Operating Procedures (SOPs) * Mentoring and training staff * Attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings Qualifications Minimum Required: Bachelors and/or a combination of related experience Other_Required * 10+ years experience * 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 leadership and interpersonal skills Preferred * 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 Show moreShow less