(Sr.) Clinical Trial Manager

Description

At Merida Biosciences, we are pioneering true precision medicines for antibody-driven diseases. We specifically target pathogenic antibodies and their cellular sources with bespoke Fc biotherapeutics engineered to selectively and completely eliminate the root causes of autoimmune and allergic diseases, and to achieve deep, durable responses while preserving essential immunity. We are looking for passionate individuals to join our mission to transform treatment paradigms across the spectrum of antibody-driven diseases.

We are seeking a (Sr.) Clinical Trial Manager to become an integral part of the Clinical Operations team.

Responsibilities

Reporting to the Sr. Director, Clinical Operations, the (Sr.) Clinical Trial Manager is accountable for project related delivery of clinical trials that are critical to a product’s clinical development, ensuring that they are completed on time, within budget and in compliance with SOPs, regulations and ICH/GCP guidelines.

• Project leadership of the cross-functional study team and associated meetings, including external team members, CROs and vendors.
• Supports external vendor selection and management process and assists in the development of RFPs and vendor oversight plans.
• Responsible for proactive and independent management of CROs and other vendors.
• Supports timeline and budget development for assigned studies and is responsible for delivery to both.
• Lead country and site feasibility/selection process, with a focus on providing country insights, and therapeutic expertise to ensure alignment between study execution plans and program and corporate strategy.
• Plan, negotiate, and manage site budgets as well as facilitate site contracting process.
• Oversee the development of monitoring resources, key documents/plans, periodic review of outputs, decisions and actions related to monitoring inclusive of issues, risks and decisions at the study level and implementation of appropriate mitigation strategies.
• Develop and implement robust contingency and risk management plans to solve complex issues that may impact study milestones.
• Disseminate clinical trial communications to all functional groups, inclusive of key trial performance information, enrollment, and related metrics.
• Interact with clinical research investigators, Key Opinion Leaders and sites.
• Oversight of study team and site training, inclusive of investigator meeting planning and presentations.
• Facilitation of Quality processes and Quality Assurance interactions for assigned project(s).
• Management of study drug distribution to sites and accountability processes and documentation.
• Oversight of study start-up, study management, data cleaning, and study closeout activities.
• Responsible for final study files and documentation, including eTMF, and final study data archival.
• Provides review, assistance and/or leadership for the development and writing of study protocols, study plans, CRFs, informed consent forms.
• Participate in clinical data review for assigned trials.
• May interact with Senior Management to report on progress of milestones.
• Participate in initiatives and process development and improvement contributing to functional excellence in Clinical Operations.
  
  

Requirements

• BA/BS degree in Health or Life Sciences required
• Minimum 4+ years of experience or demonstration of equivalent capability in a Clinical Trials Manager role
• Exceptional communication and interpersonal skills
• Positive team orientated attitude
• Reliable, self-motivated, team player
• Detail oriented with excellent organizational skills
• Ability to effectively manage multiple tasks and competing priorities
• Ability to travel is required
  
  

Merida Biosciences is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.