Clinical Project Research Manager - EDS/RWE/NIS
TypeFull-time job
LocationUnited States
Posted1 hour ago
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: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
Excellent written verbal and non-verbal communication skills
Excellent supervisory, interpersonal, and presentation skills
Ability to independently assess issues and/or mitigate risk by using critical judgment to come to a resolution
Solution driven
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 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
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: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
Excellent written verbal and non-verbal communication skills
Excellent supervisory, interpersonal, and presentation skills
Ability to independently assess issues and/or mitigate risk by using critical judgment to come to a resolution
Solution driven
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 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
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