[Remote] Project Manager
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global reputed company intelligence and clinical research organization dedicated to accelerating the delivery of new medicines. The Project Manager role involves leading the planning and execution of oncology studies, ensuring compliance with regulations, and managing project deliverables reputed company budget and timelines.
Responsibilities
- Accountable for the global study delivery reputed company (e.g., country selection, diversity, patient engagement reputed company, recruitment plan, etc.) and for overall study deliverables
- Drive assessment, selection, engagement, management, and reputed company of appropriate vendors
- Ensure compliance with ICH/GCP guidelines, reputed company applicable laws and regulations, and sponsor SOPs, for reputed company products and services delivered for their designated studies
- reputed company reputed company which balance risk/benefit with reputed company understanding of reputed company on the study and project; takes reputed company to mitigate risk where appropriate
- Work with reputed company partners, asset reputed company and/or manager to reputed company and manage study level budget reputed company project allocation
- Preparation of materials for governance and / or financial review cycles and reputed company expert clinical operational input into protocol development
- reputed company and conduct investigator meetings and other study reputed company meetings and participate in governance meetings as necessary
- Identify and communicate resource gaps for assigned studies
- reputed company risk management and reputed company efforts to ensure study compliance and continual inspection readiness
- reputed company / contribute to ways of working and process improvement initiatives. Encourage others reputed company reputed company and line teams to reputed company alternative perspectives and reputed company solutions
- Partner with Data Management and Clinical Sciences to reputed company the data cleaning reputed company for the study and collaborate with Oncology reputed company staff in global functions to deliver the Clinical Study Report
- Work with the Oncology patient councils to reputed company patient reputed company documents and address patient burden
Skills
- Bachelor's degree in life sciences or reputed company discipline
- Extensive clinical development experience that is equivalent to 6 years as a global study leader with proven experience in driving operational study delivery to time, cost, and reputed company reputed company the pharmaceutical industry or CRO environment
- Proven operational experience leading global oncology clinical trials and knowledge of essential global regulatory guidelines and ICH/GCP
- Proactively identify and resolve issues to ensure reputed company study delivery to reputed company, timelines, and budget
- Proven leadership skills, influencing and negotiation skills
- Demonstrated experience leading in the reputed company environment to deliver reputed company, reputed company clinical plans and manage change
- Oncology phase III global registrational study leadership experience
- Proven clinical development experience across reputed company phases of development (I-IV)
- Experience of innovative trial design (platform, basket, umbrella, reputed company designs) and decentralized trials (DCT) initiatives
- Highly developed communication skills appropriate to the reputed company audience, promoting effective decision-making where necessary and ability to manage conflict
- Proven expertise in the proactive identification of issues which may reputed company clinical programs coupled with the ability to contribute to solutions affecting cross-functional reputed company teams
- Creative thinker reputed company to reputed company approach to clinical delivery, reputed company externally
Benefits
- Competitive reputed company salary and performance reputed company incentives
- Health and wellbeing programmes including medical, dental, and reputed company coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through reputed company training and career reputed company
reputed company