13 Sep
|
Precision for Medicine
|
Gold Coast
13 Sep
Precision for Medicine
Gold Coast
Senior Clinical Project Manager/Clinical Project ManagerPrecision for Medicine is not your typical CRO.
At Precision for Medicine we have brought together current technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.
What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences.
We have a strong focus on Oncology and Rare Disease.Position Summary:The Senior/Project Manager plans, directs, coordinates, and delivers activities for designated clinical study projects to ensure that project objectives of quality, scope, cost, and time are accomplished.Essential functions of the job include but are not limited to:Serve as primary point-of-contact and primary escalation point to the clientCoordinate and oversees all functional services including external vendors to the established timeline and budgetManage the study budget, ensuring project remains within scope and that any out of scope activities are identified early and handled as appropriate.
Independently drive the CO to completion and execution with support as needed.Maintain integrated collaboration with clinical operations in the delivery and participates in clinical activities as appropriate.
For projects of very limited scope (i.e. number of sites), Sr.
PM may assume all clinical activitiesManage the financial health of assigned studies, including oversight of the project profitability, billable project hours, and compliance with on time, accurate billing and forecasting to support business objectives.Develop robust and comprehensive project plans, including timelines and proactive risk management and mitigation, to guide all parameters of trial execution with consistency and qualityEnsure Quality management for assigned projects, including eTMF Inspection readiness,
implementation of quality notification incident forms and / or corrective and preventative action plans to address any quality findings.Maintain integrated collaboration with all functional operations in the delivery of the program and review as necessary of other study documentationEstablish tracking metrics to monitor trial and team progress towards project goalsPrepare project status updates and report on progress to clients and senior management, including reporting on key performance indicators, offering solutions and opportunities as they ariseLeads both internal and client meetings and set expectations for the project teamCommunicate effectively with client and Precision management to relay protocol/study issues including any deviations and implements necessary actions in response to those issuesAbility to conduct formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients including Bid Defences with proficiencyEnsure study specific training is implemented in collaboration with functional areas and ensure study specific training compliance for the duration of the projectSupport business development and marketing activities as appropriate, including travel to Bid Defense meetings as requiredPerform other duties as assigned by managementRemain compliant with organisational training, time-reporting and any other administrative duties as requiredProvides on-going feedback, for functional team members including annual performance reviewsBachelor's degree or equivalent combination of education/experience in science or health-relatedAdvanced degree preferredMinimum of 7 years of clinical research experience or proven competencies for this position anda minimum of 4 years of direct project management experienceExperience in managing complex and global trialsAbility to travel domestically and internationally including overnight staysOther Required:Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) Microsoft Project,eTMF, EDC and CTMSProven communication and interpersonal skills to effectively interface with others in a team settingProven organizational skills, attention to detail,
and a customer service demeanourDemonstrates knowledge of ICH-GCP, relevant Precision SOPs, as well as the ability toimplement such itemsProven knowledge of project management techniques and toolsDirect work experience in a global, cross-functional project management environmentGood understanding of cross-functional managementGood understanding of project planning, risk management and change management with anawareness of appropriate escalationProven experience in strategic planning, risk management and change managementHigh level of integrity and must inspire and demand the highest standards from a professionaland ethical perspectiveAbility to lead and inspire excellence within a study teamAbility to create an environment where study team members have a sense of ownership that willlead to increases in productivity and efficiencyResults oriented, accountable, motivated and flexibleProven time management, negotiation, critical thinking, decision making, analytical andinterpersonal skillsProven presentation, verbal and written communications skillsGood understanding of project management softwareWe invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies.
We strive to ensure employees feel appreciated for the contributions they make every single day.
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Precision Medicine Group is an Equal Opportunity Employer.
Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at .
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📌 Senior Clinical Project Manager/Clinical Project Manager (Gold Coast)
🏢 Precision for Medicine
📍 Gold Coast