Senior Project Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the implementation of clinical research initiatives or programs, ensuring adherence to relevant regulations, guidelines, and corporate policies.

• Manage projects throughout the entire lifecycle, including scope definition, budget management, and resource evaluation.

• Serve as the main point of contact between the organization and sponsors for project initiation, execution, and completion.

• Engage in communication with sponsors, cross-functional teams, project vendors, and site personnel.

• Provide updates on project status, create regular reports, and prepare formal presentations.

• Collaborate with clinical, marketing, and operations management to establish study objectives and scope.

• Ensure the operational and regulatory integrity of assigned studies.

• Participate in inspections by the FDA or other regulatory bodies as required.

• Create study plans, informed consent documents, case report form instructions, site selection materials, investigator updates, and other relevant project documentation.

• Identify project risks and evaluate impacts on scope, costs, resources, and timelines.

• Develop, manage, and monitor project budgets.

• Apply project management tools, techniques, and processes to facilitate informed decision-making.

• Engage in clinical data review and analysis.

• Provide training, mentorship, and coaching to junior staff while offering constructive feedback.

• Ensure that tasks align with client expectations and adhere to contracts, trial protocols, and SOPs.

• Contribute to the ongoing enhancement of project delivery practices.

• Stay updated on FDA regulations, as well as GCP and ICH Guidelines.

• Supervise team members and offer higher-level guidance on project management tools and methodologies.

• Attend off-site meetings and conferences as necessary.

⛳️ Requirements

• A Bachelor's degree or equivalent in life sciences/healthcare is mandatory.

• A minimum of 8 years of experience in clinical project management within a local medical organization, investigational site, pharmaceutical company, CRO, or clinical fellowship program.

• Experience within a CRO is highly preferred.

• Proven ability to qualify and manage external vendors.

• Experience in leading project operational teams through the start-up phase, study execution, data management, and clinical report writing.

• Proficient in writing, reviewing, and editing clinical protocols and study reports.

• Familiarity with the FDA submission process.

• Knowledge of FDA regulations along with GCP and ICH Guidelines applicable to clinical research.

• Exceptional organizational and coordination skills.

• Strong teaching and facilitation abilities.

• Ability to evaluate training needs and objectives.

• Extensive experience in overseeing and coordinating the efforts of others.

• Capability to manage multiple tasks simultaneously while meeting various deadlines.

• Ability to exercise sound judgment and determine suitable actions for problems of differing complexities.

• A strong desire to take ownership of multiple projects.

🏝️ Benefits

• Opportunity to attend off-site meetings and conferences as required.

• Access to educational opportunities and professional development through reading professional publications, maintaining professional networks, and participating in professional organizations.