Senior Clinical Project Manager (m/w/d) - Remote

BD; United States; Remote; USD 101,000 - 146,000; Full time

Job summary

BD in Germany seeks a Senior Clinical Project Manager to lead multiple, high-complexity clinical trials from protocol through close-out in compliance with GCP, FDA, ISO, MDR/IVDR standards. You will mentor other PMs and CRAs and coordinate with CROs and internal BD teams across borders.

The role requires a life sciences degree, 4+ years PM experience, and 6+ years of clinical study experience, plus travel ~20%.

Qualifications

• Minimum 4 years of project management experience.
• Minimum 6 years of clinical study experience, in medical device, IVD, pharmaceutical, biotechnology, CRO.
• Familiarity with CLSI guidelines and related standards.
• PMP certification is a preferred goal for Clinical Project Managers.
• Proficient understanding of GCP, FDA and ISO regulations, MDR/IVDR and related industry practices.
• Ability to travel approximately 20% worldwide.

Responsibilities

• Lead and manage complex clinical trials from protocol development through conduct and closeout.
• Ensure execution within study timelines and deliverables; manage risks and issues.
• Collaborate with global project management, DM and Statistics, and Medical Affairs.
• Oversee and train study-specific local resources (contractor CRAs, CROs).
• Develop and oversee clinical study budgets including invoices and accruals.
• Define, track and report on project management schedule attributes.

Skills

Project management

Team leadership

Communication

Negotiation

Independent work

Travel readiness

Education

Bachelor's degree in life sciences or related field

Job description

Location: Germany

About the Role

Working within the Global Clinical Affairs (GCA) organization, the Senior Clinical Project Manager is responsible for clinical trial management of multiple studies and may be subject matter expert for group or platform of assigned clinical studies including the planning, implementation, oversight, project management and completion of clinical trials conducted by GCA or Contract Research Organizations (CRO). The Senior Clinical Project will also serve as mentor to other Clinical Project Managers and CRA’s. This role serves as the project lead for multiple studies of high complexity from protocol development through study conduct and close out in compliance with Good Clinical Practices, and all Global, National and Local Regulations. Reports to and collaborates with the Clinical Program Manager and Director, OUS Clinical Affairs to review business requests and evaluate or develop early plans and concepts for optimal study execution.

Furthermore responsibilities in Detail:

• With limited supervision, serve as Senior Clinical Project Manager in complex clinical trials
• Ensures execution within overall study timelines and deliverables and delivers accordingly for his/her studies.
• Proactively identifies, escalates and manages risks and issues to ensure cost-effective timely delivery of the project
• Collaborates actively with other GCA functions, e.g. global project management, as applicable, DM and Statistics
• Collaborates with the Medical Affairs departments of the BD Business Units
• Oversees/leads and trains study-specific local clinical resources, e.g. contractor CRA, CRO, etc.
• Provides critical thinking and escalates accordingly when issues arise during execution of clinical studies.
• Oversees study quality and implements high quality standards in order to meet compliance requirements
• Contributes to continuous improvement activities/initiatives,
• Manages relationships with sites/PIs and other study-related vendors, e.g. CROs, central labs, etc.
• Develop and/or oversee the development of clinical study budgets, including invoice review/approval and monthly accruals
• Defines, tracks and reports on project management schedule attributes such as durations, interdependencies, milestones, critical path and other key deliverables including efficiency and effectiveness of plans and staff

About You

• Bachelor's degree required, preferably in the life sciences, clinical or other relevant technical areas
• Minimum of 4 years project management experience
• Minimum 6 years of clinical study experience, (e.g., preferably in medical device, or in IVD, pharmaceutical, biotechnology, CRO) including the proven ability to oversee clinical teams in the conduct and report of multicenter, global complex studies
• Familiarity with CLSI guidelines and other standards
• Demonstrable Project Management skills; PMP Certification is a preferred goal for all Clinical Project Managers;
• Proficient understanding of Good Clinical Practice (GCP), FDA and ISO regulations, MDR/IVDR and current industry practices related to the conduct of clinical studies
• Knowledge of clinical trial concepts and practices, including international clinical research guidelines and regulations
• Strong client and vendor relationship management skills
• Ability to work effectively, mostly independently in international teams, manage multiple projects and work in a fast paced and changing environment
• Demonstrated and effective interpersonal, communications and negotiation skills for a wide variety of audiences
• Ability to work effectively in a virtual environment
• Ability to travel approximately 20%, worldwide

Our Offer

A professional challenge in a highly motivated team, a global environment and with long-term perspectives. A familiar working atmosphere in an innovative environment where your opinion matters. Diversity characterizes our corporate culture and we are convinced that it makes us a stronger team. We value each person as an individual with their abilities and needs. In this sense, we welcome applicants who wish to work part-time, people with severe disabilities and applicants of any gender.

BD is one of the largest international medical technology companies, dedicated to advancing the world of health through improvements in medical research, diagnostics, and the treatment and care of patients. The company develops innovative technologies, services, and concepts that help improve patient care as well as workflows in everyday clinical practice. Worldwide, it employs BD 70,000 employees and employees and is represented in almost all countries to address the most pressing challenges in healthcare. BD supports its customers in achieving better clinical outcomes, reducing costs, increasing efficiency in the clinic and laboratory, improving patient and user safety, and improving access to healthcare. bd.com