Responsibilities:

Project Planning & Delivery 

• Support development and maintenance of project plans, timelines, milestones, deliverables, and resource requirements.

• Coordinate biometrics activities across Biostatistics, Statistical Programming, and Data Management.

• Track study progress against contracted scope, timelines, and key milestones.

• Follow up with functional leads and team members regarding deliverables, dependencies, and outstanding actions.

• Support database lock, analysis, reporting, and other critical biometrics milestones.

• Assist with planning and coordination of multiple studies or workstreams. 

Client & Team Communication

• Participate in client and internal project meetings.

• Prepare meeting agendas, status updates, meeting minutes, and action-item trackers.

• Facilitate routine project meetings as experience develops.

• Maintain clear communication among clients, functional leads, and project team members.

• Escalate potential timeline, scope, resource, or quality issues to the appropriate PM or functional leadership.

Risk & Issue Management

• Maintain project risk, issue, decision, and action logs.

• Identify emerging risks related to timelines, dependencies, resources, scope, and deliverables.

• Support development and tracking of mitigation and recovery plans.

• Proactively communicate potential delays and dependencies to the project team. 

Scope & Financial Management

• Support tracking of project budgets, hours, milestones, and financial performance.

• Monitor work performed against the contracted scope of work.

• Identify potential out-of-scope activities and communicate them to the Project Manager.

• Assist with preparation of change-order information, forecasts, and project financial updates. 

Quality & Compliance

• Support delivery of projects in accordance with applicable SOPs, client requirements, contracts, and quality standards.

• Ensure project documentation and trackers are accurate, current, and appropriately maintained.

• Work with functional teams to support timely resolution of project-level quality issues.

• Support inspection- and audit-readiness activities as required. 

Skills and Qualifications:

Requires a bachelor’s degree or higher in life sciences. MBA or PMP is preferred.

• 0-2 years of relevant experience in Pharma/CRO industry. Basic understanding of the clinical drug-development process and clinical trials.

• Previous experience in project coordination, clinical operations, Data Management, Biostatistics, Statistical Programming, or another biometrics function is preferred.

• Familiarity with project management concepts such as scope, timeline, budget, risk, dependencies, and change control.

• Knowledge of FDA regulations, drug development and PM processes • Good understanding of ICH/GCP guidelines.

• Strong written and verbal communication skills.

• Strong organizational and time-management skills.

• Detail-oriented with strong follow-through.

• Strong team player and interpersonal skills and customer focused.

• Proficiency in Microsoft Word, Excel, Power Point, Outlook and MS Project. 

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.  The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Project Management

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