Join an enthusiastic Clinical Development team in a growing drug discovery company. Spero Therapeutics seeks a motivated and team-oriented individual who will be a key contributor to the overall success of Spero’s clinical development program. The Clinical Project Manager will be responsible for a broad scope of varying activities to support department and corporate goals.
- Plan and implement Phase 1 anti-infective clinical research studies on schedule and within budget.
- Coordinate and lead study team meetings and update the Clinical Development Team on timelines and progress toward milestones.
- Coordinate activities and provide oversight of vendors and investigators to ensure compliance with the study protocol and overall clinical objectives.
- Contribute to the development of study documentation including but not limited to protocol review, study manual creation and eCRFs design.
- Ensure that study documentation is maintained according to applicable regulations, industry accepted standards, and SOPs that govern clinical studies both in the field and in-house.
- Participate in study site selection; review and update site specific consent forms; track patient accrual and study progress via standard reports; assure patient eligibility; document protocol deviations/violations; and manage adverse event reporting.
- Oversee clinical monitoring from site qualification to site closure visits and assure integrity of clinical data with respect to accuracy, accountability and documentation through review of case report forms, source documents, and medical records. Evaluate and analyze clinical data.
- Provide input to Clinical Study Reports and Investigator Drug Brochures, including data cleaning, listing review, and report writing.
- Develop standard operating procedures (SOPs), work instructions (WIs), and standardized forms to define Clinical Department processes within a small but growing team.
- Collaborate with Clinical, Regulatory, and Quality team members to ensure compliance of department/study activities with FDA regulations, guidelines, and principles of ICH GCP and Spero SOPs.
- Review and negotiate contracts.
- Limited travel (<20%) likely for site and vendor oversight.
Qualifications and Experience
- Strong oral and written communication skills
- Monitoring, study management, and SOP-development experience
- Highly adaptable, proactive, deadline and detail-oriented
- High level of professional expertise through recent industry training and familiarity with clinical research publications
- Quality (GCP) and/or Data Management experience is a plus
- The candidate will work independently under general direction in a fast-paced environment
- Preferred Education/Experience: BS 4-8; MS 2-6.
Spero has a vibrant and engaging culture of innovation and team work and we are continuing to build a top-tier team to rapidly advance our programs in a fast-paced, exciting and fun work environment. We offer a robust benefits package including premium health/dental plans, 401(k) retirement plan, incentive stock options, 4 weeks paid time off, professional development, and frequent social opportunities.
Please forward your CV/resume to Careers@sperotherapeutics.com
Spero Therapeutics, Inc. 675 Massachusetts Avenue, 14th Floor, Cambridge, MA 02139