United-Biosource-Corporation

As a pharmaceutical support industry leader, UBCis devoted toempowering health solutions for a better tomorrow. We takeprideinimprovingpatient outcomes andadvancing healthcare.At UBCwe provide services to enhance the entire drug development process and commercialization lifecycle - From clinical trial support to real-world evidence generation. Embark on a rewarding career journey with UBC! Grow your career while making a meaningfulimpacton theworldaround you.UBCfosters a culture built on our Core Values being: Collaborative, Conscientious, Curious, Consultative, and Compassionate. We believe in aninclusive workplacethat fosters creativity. If you are seeking a career that willchallenge, inspire,andrewardyou, join us atUBC! Job Title: YLM01H – Clinical Project Research Manager Brief Description : Plan, organize and lead UBC project teams to deliver projects based on client needs on time, on budget, and within scope Specific job duties: Oversee all aspects of project conduct from start-up through close-out Execute operational aspects of assigned project activities as well as special projects Manage project per the scope of work and within the contracted budget Manage revenue and invoicing for project(s) Ensure project is conducted according to UBC SOPs and client SOPs as applicable Develop plans and processes to achieve contracted milestones (e.g. project plan, clinical management plan, monitoring plan, training plan, communication plan, compliance plan); monitor project progress against the established plans and ensure compliance with plans Prepare project timelines and prepare or coordinate development of deliverables Prepare project meeting agendas and create minutes and actions logs Ensure project budget is tracked against contract milestones Serve as UBC primary contact with sponsor Coordinate and facilitate all project meetings with internal and external stakeholders as necessary Focal point for resolving project team member questions Supervise all functional areas that support the project Lead projects with cross functional involvement and supervise all functional areas that support the project Ensure project training occurs and assist with training for project, as assigned Develop content and lead Kick off Meetings both internally and externally Negotiate budgets and assist with remediation of contract language Present project information at bid defenses, client meetings and UBC monthly project review meetings Maintain project documentation to be “audit ready” Participate in sponsor/regulatory audits as required Coordinate investigator meeting as required May be asked to assist in protocol development and/or patient/subject consent form or REMS and REMS Supporting Documents as required Help lead process improvement activities Establish, implement and track key metrics to report on progress of project and initiatives Coordinate and ensure maintenance of Trial Master File as required May be asked to perform CSS and CRA duties as needed Other duties as assigned by management Supervisory Responsibility: Supervision of project team Desired Skills and Qualifications: Bachelor’s Degree or equivalent experience Previous managerial, or relevant experience, required Very good written verbal and non-verbal communication skills Very good supervisory skills Very good interpersonal skills Very good presentation skills Ability to independently assess issues and/or mitigate risk by using critical judgment to come to a resolution Solution driven Very good knowledge of regulatory requirements (i.e. Good Clinical Practice, ICH guidelines, etc.) 10% travel as required Benefits: At UBC, employee growth and well-being are always at the forefront. We offer an extensive range of benefits to ensure that you have everything you need to thrive personally and professionally. Here are some of the exciting perks UBC offers: Remote opportunities Competitive salaries Growth opportunities for promotion 401K with company match* Tuition reimbursement Flexible work environment Discretionary PTO (Paid Time Off) Paid Holidays Employee assistance programs Medical, Dental, and vision coverage HSA/FSA Telemedicine (Virtual doctor appointments) Wellness program Adoption assistance Short term disability Long term disability Life insurance Discount programs UBC is proud to be an equal opportunity employer and does not discriminate because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state, or local protected class. We are committed to a diverse, equitable and inclusive culture that fosters respect for each other, our clients, and our patients. Originally posted on Himalayas

As a pharmaceutical support industry leader, UBCis devoted toempowering health solutions for a better tomorrow. We takeprideinimprovingpatient outcomes andadvancing healthcare.At UBCwe provide services to enhance the entire drug development process and commercialization lifecycle - From clinical trial support to real-world evidence generation. Embark on a rewardingcareer journey with UBC! Growyour career while making a meaningfulimpacton theworldaround you.UBCfosters a culture built on our Core Values being: Collaborative, Conscientious, Curious, Consultative, and Compassionate. We believe in aninclusive workplacethat fosters creativity. If you are seeking a career that willchallenge, inspire,andrewardyou, join us atUBC! Job Title: YLM03H – Lead Clinical Research Associate (LCRA) Brief Description : Provides clinical project oversight and support to the project management (PM) team. Provides oversight and manages clinical monitoring and site management portions of projects in accordance with ICH/GCP, CFR guidelines, regional or country regulations/ legislations, as well as UBC and sponsor SOPs. Specific job duties: Thorough knowledge of sponsor-specific project requirements, scope, protocol and timelines Provides oversight of the day-to-day clinical operations of US, European and/or multi-national global projects from start-up through close-out Reviews and approves monitoring reports and letters within UBC and/or sponsor timelines Leads and assists with UBC and project-specific training Ensures appropriate visit scheduling per protocol; tracks, reports and escalates adherence to site visit schedule, trip report metrics and documentation of completed tasks Provides oversight of the issues & actions and protocol deviations to ensure timely resolution per UBC and/or sponsor timelines Serves as primary liaison for monitoring issues, escalating to PM and/or Evidence Development Operations (EDO) Manager when appropriate Assists with preparation and leading of sponsor, project team and UBC meetings Assists as back-up for PM and may be primary contact for UBC/sponsor interaction Collaborates with PM to provide input into resourcing, analyzing cost variances, out-of-scope management, and conducting revenue recognition as applicable Coordinates site assignments for team in conjunction with PM and EDO Manager Monitors clinical operations aspects of the project against the established plans, SOPs and KPIs ensuring compliance Assists PM with the creation and maintenance of project-specific documents Responsible for maintenance of audit-ready project systems (eTMF, CTMS, project-specific systems) as related to clinical operations Mentors and supports project team May include reviewing the preparation, submission and tracking of Competent Authority (CA), Central and Local Ethics Committee and other regulatory applications, as per country requirements May include oversight of contract negotiation activities with the sites as per country requirements May be required to perform site monitoring as needed. May review and provide oversight of study feasibility assessments May assist PM and EDO Manager with management of Vendor CRAs May require up to 30% travel Assists with other duties as assigned Supervisory Responsibility: N/A Desired Skills and Qualifications: Bachelor’s degree in Health Care/Life Science preferred or equivalent industry experience Minimum of 5+ years of site management experience required with preference of 2 years field monitoring experience Knowledge and understanding of the local country laws applicable to clinical trials and observational studies Proficient in the operational methodologies of clinical trials and observational studies Thorough knowledge of medical terminology, ICH/GCP and UBC SOPs Excellent written and verbal communication skills in English and local language High attention to detail Excellent critical thinking and resolution skills Displays leadership, organizational, communication, time management and interpersonal skills Proven skills with CTMS, eTMF, EDC, Microsoft Office, basic computer software and sponsor specific systems Ability to work independently and within a cross-team environment. Confident in taking responsibility for operational day-to-day project oversight Ability to coordinate monitoring project activities at local, national, and international studies Benefits: At UBC, employee growth and well-being are always at the forefront. We offer an extensive range of benefits to ensure that you have everything you need to thrive personally and professionally. Here are some of the exciting perks UBC offers: Remote opportunities Competitive salaries Growth opportunities for promotion 401K with company match* Tuition reimbursement Flexible work environment Discretionary Time Off Paid Holidays Employee assistance programs Medical, Dental, and vision coverage HSA/FSA Telemedicine (Virtual doctor appointments) Wellness program Adoption assistance Short term disability Long term disabi