Clinical Research Project Manager
Company description
MBQ Pharma is a novel biopharmaceutical company focused on the discovery and development of innovative small molecules for the treatment of solid tumors, auto-immune diseases as well as inflammatory disorders through novel-generation solutions including Rac and Cdc42 inhibition. The company, located in San Juan, Puerto Rico has developed the MBQ-167 program, a drug technology for the treatment of metastatic and non-metastatic advanced breast and pancreatic cancer. MBQ Pharma is committed to outstanding sciences to develop novel and effective medicines that address significant unmet medical needs. We are seeking a talented and enthusiastic professional to lead our clinical operations as we are moving forward into the next stage of development.

Job description
Position Description
Formulate effective strategic objectives and assure implementation and operational integration to achieve our clinical development missions. Direct all activities required to conduct and monitor clinical trials and ensure that GCP are followed. Ensure projects are managed appropriately and efficiently.

Responsibilities
 • Play a leadership role in managing clinical trials, Phase I and beyond, across all functional areas of the drug development.
 • Provide strategic inputs including assessing operational feasibility, forecasting timelines, resources and budgets, and defining the vendor outsourcing strategy for assigned programs.
• Oversee the activities required to execute, conduct and complete clinical studies within established timelines and budgets
• Function as primary liaison for site personnel and internal company personnel regarding study-related topics and/or questions
• Act as the primary contact with CROs, sites and central laboratories for all study related matters including, but not limited to, clinical planning, patient recruitment, compliance with protocols, and monitoring of progress from start-up through final study report writing
• Establishing critical timelines and directing the activities of employees, collaborators, clinical sites, and clinical investigators to meet required deadlines and target goals
 • Assist in the selection of CROs and review study feasibility assessments and project plans provided by the CROs.
  • Oversee CROs and provide timely input to ensure the study is executed according to the agreed project plan. Ensure accurate tracking and reporting of study metrics. Prepare and track required documentation from clinical sites.
• Oversee clinical trials operations to ensure compliance with quality measures including the FDA regulations and current ICH GCP guidelines. 

• Effectively identify, communicate and mitigate program status, risks, and changes that may impact quality, timelines, and cost.
• Responsible for ongoing review of all study documents (IRB, protocol amendments, reports, etc.), informed consents, case report forms, adverse event narratives, study materials and monitoring tools, as requested.
• Continuously review data from the clinical trial database to identify abnormal results, assess clinical significance, identify any efficacy and/or safety trends and determine if a
 specific action is necessary.
• Ensure the review and tracking of monitoring reports for content, quality, timeliness, and GCP adherence
• Keep management informed by escalating issues requiring intervention
• Demonstrate professionalism and adherence to moral, ethical, and quality principles

 Qualifications
 • An advanced degree in clinical, clinical-related, or appropriate biological sciences.
• At least 2 years of leadership experience within the pharmaceutical clinical research and clinical operations.
• A broad knowledge of safety reporting principles, including FDA safety reporting regulations.
• Able to perform critical review of various medical, clinical, regulatory and safety documents.
• A proven track record in design and execution of clinical trials in multiple geographic jurisdictions, particularly the FDA.
• Outstanding presentation and communication skills (oral & written).
 • Strong leadership skills coupled with goal-oriented personality.
• Self-motivated team player and able to work independently in a multidisciplinary team of biologists, chemists, clinical partners and external collaborators in a dynamic environment.
• A strong sense of urgency, decisiveness and accountability, and experience working with aggressive timelines.
• Must be available to work in the evenings and weekends, as required.
• Experience in Oncology required
 

Position Location
 • Remote.
 • Position may require occasional travel.
  Job Types: Contract