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Clinical Data Manager

Company: Zolon Life Sciences
Location: Philadelphia
Posted on: February 16, 2020

Job Description:

Zolon is seeking an experienced Clinical Data Manager--for an rapidly growing Biopharmaceutical company in the Greater Philadelphia area.----The culture of this company is collaborative, cutting-edge, with clear intent to bring life improving therapies to the patient. This is an opportunity to be a key contributor in the success of this clinical stage Biopharma company.-- This key individual must be motivated, creative, passionate, and driven for results. Summary: The Clinical Data Coordinator III (Senior Clinical Coordinator) will work closely with the Clinical Data Manager (CDM) and the Clinical Program Managers (CPM) to oversee data management activities performed by the designated data management vendor and core lab(s) with the purpose to deliver a clean and complete database for statistical analysis. Essential Duties & Responsibilities: --- Develops/executes/reviews project documentation including but not limited to, data management plan, eCRF Completion Guidelines, Edit Check, Query Logic, UAT, and work instructions for assigned projects. --- Manages activities including Medical Coding, Data Validation Checks, and Database Snapshot. --- Lead data reconciliation of electronic data transfers from Vendor to Sponsor. --- Assist communication with database (DB) vendors on consistent basis to address clinical team requests and/or eCRF development activities. --- Provide Clinical Data Management support to cross-functional team. --- Participate in the review of Clinical Research documents (Protocols) as needed. --- Participate in UAT of eCRF build and validation documents, included but not limited to edit check document, issue logs and UAT summary report. --- Participate in the preparation and presentation of data where and when applicable. --- Ensure the quality of clinical data to support study report, IND and NDA submissions meets standards --- Support the identification, review, evaluation and implementation of new technologies related to clinical data standards. --- Ensures that data management related SOPs are up to date and are FDA compliant. --- Study Start-Up: work across several studies to ensure all required documentation is in place in order to authorize sites for study enrollment. --- Collaboration: participate in study-specific meetings, teleconferences and training. Collaborate with cross-functional team members and study sites throughout all studies. --- Mentors and guides junior level Clinical Data Coordinators and assists them in their work. Qualifications: --- Bachelor's Degree --- 3-5 years or more of direct data management experience. --- Must be able to contribute to all phases of a clinical trial on their own. --- Must have demonstrated knowledge of medical terminology. --- Experience with CROs/EDC vendors for data management activities. --- Demonstrate knowledge of problem solving (queries, edit checks, specifications, etc.) and possess analytical skills. --- Adhere to regulatory guidelines, Good Clinical Practice (GCP) Standard Operating Procedures (SOP) and client expectations --- Must have some knowledge of several datasets/programming tools (ADAM, SAS, SDTM, etc. are examples) --- Must have knowledge of personal computers, database structures and database design software (page maker, CDISC, etc.) --- Must be able to handle confidential matters --- High organizational skills, and proficient with Microsoft Excel, Word and Outlook. --- Ability to multi-task and prioritize to meet strict deadlines: support several studies and/or personnel simultaneously, work in a very fast-paced, rapidly changing environment. --- Flexibility and adaptability to organize and manage multiple projects and assignments and work with sense of urgency. --- Ability to work in a team environment and possess clear, concise communication skills, written and verbal. --- Must be comfortable interacting with site personnel via phone, email or in person. --- Vast knowledge of several EDC tools/platforms. --- Ability to prepare documents, presentations, and excel analysis with no minimal guidance. --- Positively and professionally represent Company values in all interactions both internally and externally. --- Ability to handle confidential matters and information with discretion and diplomacy and to know and practice the importance of data security.

Keywords: Zolon Life Sciences, Philadelphia , Clinical Data Manager, Executive , Philadelphia, Pennsylvania

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