Overview***This is a work from home position that can be worked remotely from anywhere in Europe***
Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences. As part of the Advanced Group family of companies, Advanced Clinical employees provide the support, structure, and professional background and experience for better clinical trials and research. They are the foundation of our energetic and collaborative environment, where constant learning and service to others take top priority. We seek dynamic, hard-working team members who are inspired to work amongst diverse backgrounds and perspectives. From our altruistic mission to outstanding career development opportunities, there's no better place to grow your career than Advanced Clinical.
A Project Manager (PM) is responsible for overseeing and conducting clinical research studies and projects. The Project Manager will oversee all assigned clinical research staff to ensure that efficient and effective management of clinical study activities is being maintained. The CM may be responsible for multiple projects and must be able to work independently and in a team environment to effectively lead and drive the project deliverables. The Project Manager will serve as a primary resource and point of communication for the client and project team.Responsibilities
- Support Proposals & Business Development as necessary to secure new business, including but not limited to, providing review and input to Requests for Proposals (RFPs) and presenting at bid defense meetings as requested
- Overall coordination and management of clinical trials from startup to closeout, within the contractual timelines.
- Project specific financial management, including but not limited to, contract adherence, budget management and regular budget reviews with the client
- Provide and/or endure study-specific training for the clinical research staff.
- Generate a comprehensive and detailed study-specific Project Plan (PP) and ensure underlying functional plans are included
- Establish and manage processes to track and analyze critical project information & metrics, including but not limited to, timeline management, project projections and forecasts, and trend and gap analyses
- Serve as the primary liaison between the AC study or clinical team and the client.
- Escalate significant issues to the Director, Clinical Operations or other appropriate AC Operational Leadership.
- Follow applicable Standard Operation Procedures (SOPs).
- Ensure compliance with applicable GCPs through training, processes, and early issue identification and correction.
- Collaborates with other functional areas to identify and evaluate fundamental issues on the project, interpret data, make good business decisions, and ensure the implementation of timely solutions.
- Develops and implements risk management strategies and contingency plans for clinical deliverables.
- Maintains a flexible approach to address issues innovatively and proactively.
- Participates in team, client, and cross functional meetings.
- Provides co-monitoring and mentoring for less experienced CRAs, as needed.
- Travel to sites, as needed to support completion and oversight of AC responsibilities.
- Oversees CRA performance, and supports workload
At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Group in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience.
- The ideal candidate should have Bachelor's Degree or RN with 5 years industry experience or a Master's degree with 3 years industry experience or an equivalent combination of education, training and experience..
- The ideal candidate has excellent organizational and time management skills and can successfully direct projects and deliverables.
- Must have proven leadership, written and verbal communication skills, and computer competence with Microsoft Word, Excel and Powerpoint.
- Advanced knowledge of and ability to apply and all applicable regulations and guidelines including GCP. Project management certification is a plus.
Equal Employment Opportunity
It is Advanced Group's practice not to discriminate against any Employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, physical or mental disability, medical condition, military or veteran status, or any other basis protected by applicable federal, state, or local law.
This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your Recruiter so that we can meet to discuss the appropriate alternatives available.