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.
1. Job Summary
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 PM 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.
2. Essential Functions
2.1. 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.
2.2. Overall coordination and management of clinical trials from startup to closeout, within the contractual timelines.
2.3. Project specific financial management, including but not limited to, contract adherence, budget management and regular budget reviews with the client.
2.4. Provide and/or endure study-specific training for the clinical research staff.
2.5. Generate a comprehensive and detailed study-specific Project Plan (PP) and ensure underlying functional plans are included.
2.6. 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.
2.7. Serve as the primary liaison between the AC study or clinical team and the client.
2.8. Escalate significant issues to the Director, Project Management or other appropriate AC Operational Leadership.
2.9. Follow applicable Standard Operation Procedures (SOPs).
2.10. Ensure compliance with applicable GCPs through training, processes, and early issue identification and correction.
2.11. 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.
2.12. Develops and implements risk management strategies and contingency plans for clinical deliverables.
2.13. Maintains a flexible approach to address issues innovatively and proactively.
2.14. Leads client and cross functional meetings.
2.15. Oversees study team member performance and assesses workload and resourcing
3. Additional Responsibilities
3.1. Perform other duties as requested by Director, Project Management
This job description is a summary of the job and requirements that are essential to the evaluation of the job. It is not intended to be complete in detail. Individuals classified in the job are required to perform the expectations for the specific job, which may, on occasion, include functions of a higher or lower skill level than is included in this classification.
4. Job Requirements
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 competency 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.
5. Minimum Training Requirements
The list below includes the general training subjects, and not necessarily the exact name of the training course obtained:
Applicable Standard Operating Procedures
21 CFR Part 11 and all applicable parts
FDA Guidance Documents including ICH E6
Drug and Device Development and Approval Process
What’s in it for you? Advanced Group offers competitive compensation, comprehensive benefits packages, and a flexible work environment designed to help our team members and their families stay healthy, meet their financial goals, and generally thrive in and beyond work. Visit the links below to discover all that Advanced Group has to offer:
Our Culture: https://careers.advancedgroup.com/embrace-our-culture
Career Development Opportunities: https://careers.advancedgroup.com/realize-your-potential
Community Programs: https://careers.advancedgroup.com/unleash-your-passion
For a complete list of all of our job openings, please visit Advanced Group’s career site here.
It is Advanced Group’s practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, 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 discuss the appropriate alternatives available.