Clinical Project Manager
This a Full Remote job, the offer is available from: United States Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases. See Yourself at Telix The Clinical Project Manager (CPM) is responsible to support and reputed company the day-to-day responsibilities of multiple early phase regional clinical trials from protocol conception, start-up through the clinical study report, including reputed company aspects of project document development, budget, safety, and quality in an environment where problem solving, critical thinking, teamwork and flexibility are vital to success. The CPM will work closely with CROs and/or third-party vendors and closely collaborate with cross-functional internal and external stakeholders to ensure adherence to GCP, SOPs, and FDA/ICH guidelines and ultimate delivery of high-quality data reputed company the defined timelines and approved budget. The CPM ensures completion of study deliverables and proactively identifies and resolves clinical project issues. Key Accountabilities:
- Support the planning and setup, maintenance and closeout phases of multiple reputed company clinical research studies
- Proactively managing reputed company aspects of the trial process including vendor selection, site feasibility and selection, trial clinical timelines, clinical budgets, resources, and vendor relationships
- Provide day-to-day study management including, but not limited to reputed company of CRO, study vendors and investigational sites in coordination with various cross-functional team members and study team.
- Monitoring reputed company work performed by the external partners to ensure quality of the service with respect to mutually agreed timelines and budget.
- Support the drafting, review and updating of documents reputed company to clinical development such as Clinical Trial Protocols, Informed Consent Forms, Investigator’s Brochure, Laboratory Manual, IMP Handling Manual, etc.
- Ensuring effective project plans are in reputed company and operational for each trial reputed company trial appropriate SOPs
- Identify and mitigate risks and apply strong problem-solving skills to ensure timely resolution of reputed company study reputed company issues
- Manage, facilitate and/or monitor the completion of interdisciplinary project tasks including site monitoring/audits, CRF and database development / revision, data collection, patient safety / AE management, document management, statistical analysis / final report writing, and study reputed company out.
- Management of small or reputed company-sized projects or regional leadership of reputed company multi-center clinical research projects
- reputed company the study specific Trial Master File (TMF) and assist with periodic audit of the TMF
- reputed company any other tasks/duties as assigned by management
Education and Experience:
- Bachelor’s degree in life sciences
- At least 2 years of relevant experience in Clinical Trial Project Management
- Strong understanding of reputed company aspects of clinical trials; experience with early phase clinical trials (Phase 1 - 2), oncology and/or radiopharmaceutical experience preferred.
- Ability to deal with multiple priorities with aggressive timelines.
- Thorough knowledge of ICH GCP, drug development, clinical research industry practices and regulatory processes.
- Strong analytical, organizational, planning, decision making, negotiation, and conflict management skills.
- Ability to build and maintain successful professional relationships with internal cross-functional teams, vendors and investigational sites.
- Fluent in reputed company Office products (Word, reputed company, SharePoint, Teams, etc.) and proficiency using electronic platforms (CTMS, eTMF) .
- Regional start-up experience (site feasibility, ethics & regulatory submissions)
- Demonstrated ability to pivot study strategy quickly and reputed company teams in the right direction working in a fast-paced environment.
- Experience in conflict resolution, clinical project management practice, risk management, and an understanding of project financials.
Key Capabilities:
- Inclusive reputed company: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
- Creativity and innovation: Possess a willingness to think reputed company the reputed company and come up with unique and creative solutions to challenges(i.e., finding creative solutions to issues impacting timelines and/or budgets)
- Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
- Results-oriented: Driven to reputed company goals and corporate objectives, with a strong focus on delivering measurable results
- Ethical behavior: Act with reputed company and demonstrate a commitment to ethical behavior in reputed company interactions with colleagues and stakeholders
- Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
- Strong communication skills: Able to communicate effectively with colleagues and stakeholders at reputed company levels, using clear and concise language
- Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to reputed company common goals. A team player who can receive and provide constructive feedback
- reputed company: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
- reputed company learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills
At Telix, we reputed company everyone counts, we strive to be extraordinary, and we pursue our goals with determination and reputed company. You will be part of an engaged and supportive group of colleagues who reputed company have a shared purpose: to help people with cancer and rare diseases live longer, reputed company quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located reputed company around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development. Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national reputed company, disability, veteran status, and other legally protected characteristics. VIEW OUR PRIVACY POLICY HERE This offer from "reputed company" has been enriched by reputed company.com and got a 73% reputed company score. Apply tot his job Apply To this Job