Xcene Research is a cutting-edge Contract Research Organization providing full-service support to pharmaceutical, biotechnology and medical device companies as well as academic institutions.
Job Title:Project Manager(MBBS Only)
Employment Type: Full Time
- Achieves study objectives by working with team members to set project priorities and milestones and resolve project conflicts.
- Owns the sponsor relationship and is responsible for sponsor communication.
- Optimizes processes for projections including cost, enrollment and Investigational Product forecasting.
- Implements standardized project plans and planning processes.
- Implements an efficient contracting and vendor selection process.
- Establishes efficient vendor management processes.
- Establishes standardized metrics and optimal reporting formats.
- Develops and maintains SOPs and work practices applicable to a global organization.
- Periodically reviews processes across clinical trial projects to ensure compliance and consistency.
- Participates in, or leads, infrastructure development project teams to enhance department growth.
- Lead strategic level work (e.g. partnership collaboration meetings, etc.)
- Provides a central point of study contact and single point of escalation on behalf of the functional teams (clinical, data management, biostatistics, medical writing, logistics, contracts, finance, medical and pharmacovigilance).
- Proactively communicates with the sponsor and internal groups ensuring that they have all the information required on project progress and status (risk analyses, what-if scenarios, contingency plans, technical information, significant changes of any kind, etc.).
- Provide proactive decisions /solutions and how the project objectives are being or should be, achieved.
- Prioritize effectively and respond to urgent requests within the team or from the sponsor.
- Maintain a positive, results-orientated work environment, building partnerships and model teamwork, communicating to the team in an open, balanced, and objective manner.
- Lead team meetings on a regular basis with the project team.
- Lead regular meetings/calls with sponsors to ensure they are fully informed of project progress, proactive decisions/solutions and how the project objectives are being achieved.
- Communicate fiscal, contractual, resource, deliverable and sponsor-related issues to management as appropriate.
- Accountable for sponsor satisfaction as measured by client survey responses and repeat business.
- Support with pre-award activities, including presentations and meetings.
- Manage study start-up activities.
- Initiate the project following a review of Lessons Learned to ensure current Best Practices are implemented.
- Define, plan and provide oversight of site selection strategy.
- Review the applicable project contract/exhibit and provide comments as appropriate.
- Lead the project such that it is completed within budget, schedule and according to contract specifications.
- Ensure the project is progressing according to quality standards, SOPs, ICH-GCP and/or other guidelines to fulfil local regulations.
- Ensure information entered relevant Xcene management systems is accurate and updated on a regular basis.
- Oversee maintenance and quality check of regulatory files/investigator site files.
- Address identified and escalated project issues and drive to closure.
- Coordinate monitors and vendors according to the monitoring plan/contractual obligations (as applicable).
- When required, review monitoring visit reports and ensure issues are resolved in a timely way.
- Review monitoring feedback and ensure issues from on-site monitors are resolved in a timely way.
- Monitor study timelines, patient/subject recruitment, retention and data cleaning to ensure a successful outcome of the project.
- Prepare, participate in and follow up on audits/inspections.
- Identify and manage/communicate CIS (changes in scope) in a timely manner if applicable.
- Manage the project budget including providing input into revenue recognition, milestone payments and monthly pass-through invoices.
- Oversee all administrative closeout procedures are completed, including IRB termination, final milestone payments are billed, etc.
- Ensure the project is archived and all documentation returned to the sponsor as specified by the contract.
- The lead end of study meeting to ensure lessons learned information is documented and passed on via appropriate channels.
The above statements are intended to describe the general nature and level of work to be performed by people assigned to this job.
They are not to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
All personnel may be required to perform other responsibilities in addition to those specified from time to time, as needed
• We do not charge any application, processing, training, interviewing, testing or other fee in connection with the application or recruitment process. Should you receive a solicitation for the payment of a fee, please disregard it. Furthermore, please note that emblems, logos, names and addresses are easily copied and reproduced. Therefore, you are advised to apply particular care when submitting personal information on the web
• We are an equal opportunity employer and value diversity inclusion. We do not discriminate on grounds of colour, race, nationality, religion, age, ethnic origin, disability, gender, marital status, or sexual orientation in our employment practices
• Our people are all equally gifted in unique ways: we come from diverse traditions, personal experiences and points of view. And we want to include yours, Are you ready to inspire us with your ideas?
• We encourage all applicants to apply and does not practice any discrimination in any recruitment process.
• Applications submitted after the deadline will not be considered.
• Due to the urgency of the position, we have the right to recruit a candidate who matches the required profile before the above deadline
• Only qualified candidates will be invited for interview
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