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Altasciences is seeking a Project Coordinator to support end-to-end clinical trial execution, coordinating study activities, timelines, risks and documents in collaboration with the PM, sponsors, vendors and internal stakeholders.
You will help maintain Trial Master File records, support GxP compliance, start-up activities with sites, and contribute to lessons learned for process improvement.
About The Role The Project Coordinator supports the end-to-end execution of clinical trials by coordinating study activities, evaluating study information, tracking risks, maintaining inspection-ready documentation, and exercising judgment to prioritize actions, identify issues requiring escalation, and support timely decision-making in collaboration with the Project Manager (PM), study team, sponsors, vendors, and internal stakeholders.
Develop, maintain, and evaluate project-specific timelines in collaboration with the PM to support on-time execution and delivery from project award through archival. Coordinate study-related issues in partnership with the PM, assess urgency and potential impact, and elevate matters appropriately. Maintain effective and timely communication with internal and external stakeholders, including sponsors, clinical sites, vendors, and cross-functional study team members, to support alignment and resolution of outstanding items. Prepare, support, and document internal and external project team meetings, including tracking decisions, action items, follow-ups, and items requiring PM or leadership input. Support the development, review, and maintenance of project-specific documents and plans. Create, maintain, and/or coordinate Trial Master File documentation and related study records to support inspection readiness, including identifying documentation gaps and driving follow-up to resolution. Coordinate with Quality Assurance and project team members to support GxP and regulatory compliance. Coordinate start-up activities with vendors and external sites. Support submissions to institutional review boards and regulatory agencies. Participate in Lessons Learned meetings and contribute observations, process gaps, and improvement recommendations to support department and corporate initiatives. Maintain risk-related trackers or risk register items. Coordinate project-specific training documentation by tracking finalized documents, confirming required training audiences, and escalating missing or delayed training inputs when needed.
The salary range estimated for this position is $47 440 and $63 253. Please note that salaries vary within the range based on factors including, but not limited to, prior relevant experience, skills, education, certification, location as well as internal equity and market data.
Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.
Altasciences’ Incentive Programs Include:
At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you're a recent college graduate or seeking your next career opportunity, it's time to discover your future at Altasciences. We are better together and together We Are Altasciences.
Altasciences is an equal opportunity employer committed to diversity and inclusion.
Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives.
All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation.
Reasonable accommodations for persons with disabilities during the recruitment process are available upon request.
Join us at Altasciences!