Quality Assurance Engineer
Incubate Labs Pvt Ltd
PRA Health Sciences
Do you want to watch clinical development change or be the one to shape it?
Because we’re hoping you’re here for the latter.
Who are we? we are pra.
We are 20,000+ employees strong, operating in more than 90 countriesWe are committed to saving lives and constantly striving to be the best at what we doOur impact is real, and we see it every single dayWe help get life-saving drugs into the hands of those who need them most.
What will you be doing?
The project manager (pm) is responsible for owning and achieving interim and final contractual deliverables for assigned projects/programs, according to time, quality/scope and cost constraintsThe pm manages the execution of day-to-day work results for projectsThe pm leads and directs cross-functional teams, understands and manages client expectations/needs to achieve client satisfaction and ensures adequate internal and external communication of informationThe pm proactively identifies, resolves/mitigates and escalates risks and/or issuesThe pm adheres to ich/gcp guidelines, local laws and regulations, and pra standard procedures and processesThe senior pm may act as global or lead project manager in multi-national, multi-site projects/programsConsequently, the senior pm may provide oversight to other members of the project management group and may lead special departmental projects/initiativesIn multi-country trials a project manager may be responsible for coordinating country specific study activities only and may report into a global lead pm who acts as primary client contact responsible for achieving contractual deliverables.
Acts as primary liaison with client:
Acts as lead contact for project matters.
Understands/manages/satisfies client contractual, organizational and relationship needs/expectations.
Oversees all start-up activities to ensure timely regulatory approval and study start.
For nl & pps only – oversees regulatory timelines, preparation, submission and approval
Provides regular reporting on project metrics, status of deliverables and risks/issues with the associated management plan to client.
Chairs and leads customer meetings and documents meeting outcomes.
Leads and directs cross-functional team leaders and third parties/vendors with close supervision and support
Oversees, coordinates and reviews work produced by project team members per the agreed upon scope of work.
Guides and supports team leads in project-specific prioritizing, trouble-shooting and contingency planning.
Delegates whilst retaining ownership.
Communicates project specific priorities to project team and provides guidance/mentoring as needed.
Ensures up-to-date planning information is available to project team and rest of operational organization
Chairs internal project team meetings and documents meeting outcomes.
Liaises with functional leads/managers to optimize performance and utilization of project team members.
Provides feedback on project team member’s performance to respective line-managers
Manages project contractual deliverables (with close supervision):
Monitors and ensures adherence to the contractual agreement (time, quality/scope, and cost deliverables).
Proactively identifies and evaluates alternative solutions to resolve/mitigate and escalate risks and/or issues as appropriate.
Manages project costs (with close supervision):
Proactively and timely identifies, for assigned projects, ensuring out of scope activities are approved up front via a contract modification.
Identifies potential or actual unrecoverable effort and provides analysis and mitigation/resolution plan for senior management’s approval.
Ensures control of financial risk to pra.
In cooperation with the project analyst, applies efficient management of project pass-through costs and investigator payments for external non-pra sites to ensure all such costs are recovered in a timely manner, and in advance where ever possible.
Leads presentation of financial reviews and is accountable for action item follow up.
Ensures that the progress of a clinical trial is conducted and complies in accordance with the protocol, pra’s standard operating procedures (sops), ich/gcp and applicable regulatory requirements at the project level
Assumes project leadership role in compliance at project level to pra processes and systems, including escalation to relevant functional and operational management
May participate in and attend the bid defense process
Support business development department by functioning as point of contact / consultant for clients and business development during sales cycle in general and more specifically during the rfp process.
May serve as the operational rfp lead and take the independent lead in supporting the feasibility, proposal and budget process.
What do you need to have?
An undergraduate degree (in health sciences from an accredited institution or internation equivalent degree)
Minimum 3 years experience in clinical research, including a management role as a team lead or project manager experience.
Phase i experience is preferred.
Read, write, and speak fluent english, fluency in the language of the host country required.
To qualify, applicants must be legally authorized to work in the united states or canada, and should not require, now or in the future, sponsorship for employment visa status.
Pra is an eeo/aa employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
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