Sr. Clinical Project Manager (United States)

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Sr. Project Manager (Sr. PM) to join our A-team (hybrid*/remote). As a Sr. Project Manager at Allucent, you are responsible for the overall coordination and management of clinical trials from start up through to final delivery. This position directs the technical and operational aspects of clinical projects - all with the sense of urgency expected of Allucent customers. Candidate must have experience in managing Government and Vaccines or COVID-19 clinical trials. Preferably familiar with decentralized clinical trials

In this role your key tasks will include:

Responsibilities:

• Leads the project team, ensuring the project is delivered according to planned scope and timelines in accordance with the contract
• Creates and executes project management plans required for project delivery and in accordance with established processes
• Ensures quality and adherence to the relevant policies, SOPs, and working instructions, GCP and regulatory guidelines.
• Establishes clear communication lines and escalation pathways, communicates with project stakeholders
• Provides input on study related documents such as the study protocol, CRF, Medical Review/Monitoring plan, and Clinical Study Report
• Establishes requirements for and ensures project specific training plan for team activities
• Leads internal and external meetings, with internal and sponsor teams, including Kick Off Meetings (KOM) and Investigator Meetings based on project scope
• Provides support for vendor identification, qualification and selection and manage vendors
• Manages vendors and vendor relationships as required for project delivery
• Ensures effective and efficient resource utilization across projects and programs
• Produces, maintains and circulates project progress and status reports
• Manages the study budget, including monthly invoicing.
• Establishes project risk management plan with input from client and functional stakeholders and oversees adherence and updates throughout the project lifecycle
• Proactively recognizes and addresses any changes in scope
• Negotiates and influences internal and external team members in a professional manner and with successful outcomes
• Effectively solves problems with projects teams by applying strategic thinking and conflict resolution skills
• Conducts review of initiation, monitoring and close-out visit reports
• May perform co-monitoring visits
• Ensures the Trial Master File is kept up to date and inspection ready

Client management:

• Serves as the primary point of communication between the sponsor and project team

Leadership:

• Leads by example and encourages team members to develop strong solutions for clinical trial delivery
• Responsible for oversight of project team delivery and communication with functional managers, including performance feedback

Requirements

To be successful you will possess:

• Minimum Bachelor’s degree in life science, healthcare and/or business degree
• Minimum 5 years of relevant work experience
• Minimum 5 years of experience in drug development and/or clinical research, with at least 2-3 years of clinical trial project management experience
• Preference for candidates with CRA experience
• Expert knowledge of ICH-GCP(R2), data and patient privacy practices, and applicable (local) regulatory requirements
• Demonstrates strong financial acumen, administrative excellence and analytical skills
• Experience managing all phases of the full-service clinical trial delivery lifecycle (Start-up, Maintenance, Close-out).
• Excellent written and verbal communication, planning, critical thinking and organizational skills, including command of English language
• Representative, outgoing and client focused
• Ability to work effectively in a fast-paced challenging environment with a growing company
• Proficiency with various applications including, but not limited to, Microsoft Word, Excel, and PowerPoint required
• Strong presentation skills

Benefits

Benefits of working at Allucent include:

• Comprehensive benefits package per location
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Opportunity for remote/hybrid* working depending on location
• Leadership and mentoring opportunities
• Participation in our Buddy Program as a new or existing employee
• Internal growth opportunities and career progression
• Financially rewarding internal employee referral program
• Access to online soft-skills and technical training via GoodHabitz and internal platforms

Disclaimers:

*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”