The Clinical Trial Manager is an opportunity for a highly motivated, organized, and proactive individual to manage overall operation of several concurrent clinical studies, including project plans and timelines, budget, resource management and contract research organization management, all while ensuring compliance with good clinical practices and regulatory and other guidelines. This important role acts as a cross functional liaison to ensure study plans align with business strategies. The ideal candidate will have the ability to work with minimal supervision to lead and drive study execution and ensure milestones are achieved on time and within budget.
Clinical Trial Management
· Select and manage CROs, vendors and consultants that are involved with the clinical trial and program.
· Serve as the point person overseeing trial execution.
· Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines.
· Lead Study Team meetings, ad hoc clinical operations meetings and programs as assigned.
· Ensure study staff is appropriately trained on relevant guidelines, regulations and SOP’s.
· Ensure trial adherence to ICH/GCP/Federal and local regulations and company specific SOPs
· Assist in preparation of clinical documentation for IND updates as well as IND submission and other regulatory authority submissions as appropriate.
· Review and provide input for reports and clinical documents such as informed consent, clinical protocols, Investigator Brochure, yearly updates to the regulatory authorities and status updates.
· Review and approve clinical monitoring visit reports and ensure that all outstanding follow-up items are closed out in a timely manner.
· Responsible for communication and escalation of study related issues as required.
· Conduct periodic reviews of the Trial Master File (TMF) to ensure compliance with ICH/GCP and company SOPs as well as ensuring all appropriate documents are filed.
Provides innovative solutions to unanticipated situations as they arise and contributes ideas to improve department functioning and the future development of Idera clinical programs
Cross functional Mentoring and Leadership
· Work cross-functionally to ensure clinical program timelines and goals are met.
· Provide study-specific mentoring and/or line management for junior team members, as appropriate.
· Participate in operational improvement initiatives (e.g. SOP development, training, etc.)
· Assist with the development of the clinical components of regulatory submissions including, but not limited to: safety, interim and final study reports
Fiscal and Contracts Management
· In conjunction with finance and legal groups, facilitate the development of clinical trial agreements, work orders and other relevant documents.
· Review and approve site budgets, manage clinical trial budgets, collaborate with finance to provide input into financial reporting and projections.
· Participate in creation of scope of work, budgets, vendor performance and issue resolution.
· Reconcile and report vendor and site payments, approve invoices and change orders ensuring accuracy and timely delivery to finance.
· Highly motivated and proactive self-starter, able to organize and perform complex tasks with minimal supervision.
· Strong team participation and leadership skills, including excellent interpersonal and communication skills.
· Ability to lead teams and drive projects forward to ensuring quality data is delivered on time and according to plan.
· Strong written and verbal communication skills.
· Ability to collaborate effectively with the study team, cross functional team members and external partners (including investigator and site staff) using collaborative influence and negotiation skills.
· Ability to seek guidance when required and inform manager of situations as they arise.
Strong computer skills including knowledge of Excel, Word, PowerPoint, MS Project and Outlook.
Education & Experience Requirements
· Bachelor’s degree in health sciences or related field.
· Minimum of 5 years’ experience in clinical research with at least 2 years’ experience in Project Management and/or Clinical Monitoring preferred.
· Experience developing, reviewing and approving study operational plans including site monitoring and risk mitigation strategies, trial budgets, site feasibility and clinical metrics tracking reports
· Training and experience in applicable regulatory guidelines, including but not limited to: Good Clinical Practices, Good Manufacturing Practice, and Code of Federal Regulations.
· Management experience of CROs, Vendors and Consultants required.
· Oncology and/or Rare Disease experience is a plus.
· Internal: Clinical Development, Data Management, Statistics, Regulatory Affairs, QA, CMC/TOX, Supply Chain, Pharmacovigilance, Medical Writing, Study Physicians
External: Vendors, CRO’s, clinical research consultants, clinical research site staff
Other Job Requirements
· Some Travel Required (~20%)