USA, Remote, US
22 hours ago
REMS Project Manager - PMO

As a pharmaceutical support industry leader, UBC is devoted to empowering health solutions for a better tomorrow. We take pride in improving patient outcomes and advancing healthcare. At UBC, we 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 meaningful impact on the world around you. UBC fosters a culture built on our Core Values of Respect, Accountability, Innovation, Quality, Integrity, and Collaboration. We believe in an inclusive workplace that fosters creativity.

 

If you are seeking a career that will challenge, inspire, and reward you, join us at UBC!


UBC is seeking an experienced Project Manager with experience in the REMS industry. 


Job Title: YLM01I – Senior Clinical Project Research Manager                                          

 

Brief Description: Lead UBC project teams to deliver project milestones

 

Specific Job Duties:

Serve as the primary contact with the sponsor for all study related items, with oversight of all aspects of project conduct, from study start-up through close-out in accordance with company and project specific SOPs, guidelines, budgets, timelines and contracts Execute operational aspects of assigned project activities as well as special projectsAssist in the development and design of protocols, CRFs, regulatory documents, project master file, and other project related deliverables Ensure operational plans are developed consistent with project needs, including but not limited to, the development of communication plans, monitoring plans, project plans, training plan, study timelines, Compliance Plan and clinical management plans; monitor project progress as compared to established plans and ensure compliance with plansFacilitate and plan investigator meetings; recruit qualified investigators and assist in budget negotiations as requiredSupervise APM/PMs and other team members to ensure project deliverables and timelines are delivered accurately and timely; provide reports to the Sponsor on project progressLead projects with cross functional involvement and supervise all functional areas that support the projectAssist in revenue and invoicing for project(s)Supervise all functional areas that support the projectEnsure project training occurs and assist with training for project, as assignedServe as a resource to team members for all inquiries and issue resolution for site    management, contract budget and remediation, and regulatory document preparation Lead internal client teleconferences and/or meetings and present project information at client meetings, bid defenses and UBC monthly project review meetingsMaintain project documentation to be “audit ready” Support APM/PMs in sponsor/regulatory audits as requiredAssist in preparation of client proposals in response to RFPsEnsure project budget is tracked against contract milestones May be asked to assist in protocol development and/or patient/subject consent form or REMS and REMS Supporting Documents as requiredInitiate and lead process improvement activitiesAccurate reporting and interpretation of project metricsProposal and implementation of action plansSatisfactory delivery of contracted services and achievement of contracted milestones for assigned projectsDuties described for Project Manager and other duties as assigned by management


Supervisory Responsibilities:   

Supervision of project management staff in execution of assigned projectsPrepare PMs to make presentations to clients in defense of proposalsEnsure that the APM/PM understands the client needs once a project is awardedServe as a resource and mentor to the APM/PM in the execution of their daily activitiesProactively assist the APM/PM in anticipating and seeking resolutions to potential and actual project issuesMotivate project team members by fostering teamworkMaintain positive attitude

 

Desired Skills and Qualifications:

BA Degree or minimum 5 years of direct project management experience at a CRO or proven leadership/management experienceExcellent written verbal and non-verbal communication skills Excellent supervisory skillsExcellent interpersonal skillsExcellent presentation skillsAbility to independently assess issues and/or mitigate risk by using critical judgment to come to a resolutionSolution drivenManage competing priorities effectivelyVery good knowledge of regulatory requirements (i.e. Good Clinical Practice, ICH guidelines, etc.)10% travel

 

Expected Project Load:

2 to 3 projects depending on scope


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) OR 20 days PTO 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.

 

#LI-JM1

#LI-REMOTE

Confirm your E-mail: Send Email