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Tenax Therapeutics, Inc. (Nasdaq:TENX) is a Phase 3, development-stage pharmaceutical company focused on developing and commercializing products that address cardiovascular pulmonary diseases with high unmet medical need. Our company is committed to improving the care of patients with life-threatening diseases, to a science-centric approach to this mission, to keeping patient safety and quality at the heart of our work, and to a supportive team environment. We offer competitive compensation and benefits including a 401(k) plan, company match, and generous vacation and holiday plan. Tenax Therapeutics, Inc. is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job-related requirements.
Senior Manager, Clinical Data Management
Location
United States
Posted
84 days ago
Salary
0
Seniority
Lead
No structured requirement data.
Job Description
Senior Manager, Clinical Data Management
Tenax Therapeutics
Role Description To support our growth, we are seeking a Senior Manager, Clinical Data Management to join our team. Reporting to the Director, Data Management, you will be accountable for operations of data management activities; provide oversight of data management department activity to support execution and consistency across multiple study projects; and coordinate end-to-end Clinical Data Management deliverables, document reviews, timelines, and project risk management. You will work closely with CROs, biostatistics, clinical operations, safety, and regulatory teams to ensure functional activities are completed according to quality and industry standards. This role is ideal for a proactive, resourceful professional who is keen to grow their career while helping patients with a debilitating, often fatal disease. - Act as Data Management contact and contributor for Tenax clinical studies. - Attend various working groups where data management expertise is required. - Provide data management input into study protocols, statistical analysis plans, and clinical study reports. - Identify and drive process improvement opportunities and implement solutions to enhance data management efficiency and quality. - Contribute to SOPs, work instructions, and best practices for clinical data management. - Review and contribute to vendor statement of work and change orders. - Oversee CRO data management activities, ensuring deliverables meet quality standards, timelines, and contractual obligations. - Contribute to the design of clinical data systems based on protocol and study needs, including IRT, EDC, annotated Case Report Forms (aCRF), and validation checks. - Perform User Acceptance Testing (UAT) of the clinical database. - Review and approve study specific data management documentation (DMPs, CCGs, DTAs, Validation checks, system specifications). - Ensure compliance with FDA, ICH-GCP, and other applicable regulatory requirements across all data management activities. - Confirm procedures for blinding are in place where applicable. - Identify and communicate potential risks/challenges. - Collaborate with the study team to identify, develop, and implement risk-based solutions. - Provide oversight of data cleaning activities. - Perform internal data reviews and ad hoc reporting. - Monitor study progress to ensure successful achievement of study milestones. - Attend trial and investigator/monitor meetings as needed. - Perform other duties as required. Qualifications - BS/BA degree in life sciences, health informatics, computer science, mathematics or related field. - 6+ years with clinical data management experience in the pharmaceutical or biotechnology industry. - Demonstrated proficiency in clinical data collection, cleaning, and analysis for Phase I-IV clinical trials in a pharmaceutical industry/clinical research company. - Experience working in an outsourced data management model. - Knowledge of and experience with EDC databases, CDASH/SDTM standards, medical terminology, medical coding dictionaries, and quality control processes. - Familiarity with GCP, ICH, and FDA requirements as applicable for clinical data management. - Ability to manage multiple initiatives and shifting priorities within a small company environment. - Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment. - Flexibility, proactivity, resourcefulness, and efficiency. - Excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks. - Excellent oral and written communication skills. - Ability and willingness to travel occasionally as needed. - Legally authorized to work in the US without sponsorship. Requirements - While working remotely, you must be able to keep all company sensitive documents, IT assets, and information secure. - You will need a dedicated work area established that provides information privacy and promotes deep focus and ability to communicate via teleconference without interruptions. - You must have internet speed of at least 50 Mbps (download) and 10 Mbps (upload) (i.e., sufficient to support audio-video teleconferences). Special Working Conditions and Physical Demands - Ability to work in a remote office environment using a computer for a significant amount of time. - Must be able to work East Coast core business hours. Company Description Tenax Therapeutics, Inc. (Nasdaq:TENX) is a Phase 3, development-stage pharmaceutical company focused on developing and commercializing products that address cardiovascular pulmonary diseases with high unmet medical need. Our company is committed to improving the care of patients with life-threatening diseases, to a science-centric approach to this mission, to keeping patient safety and quality at the heart of our work, and to a supportive team environment. We offer competitive compensation and benefits including a 401(k) plan, company match, and generous vacation and holiday plan. Tenax Therapeutics, Inc. is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job-related requirements.
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