Precision for Medicine

Research, compile and analyse information on therapeutic area(s) contained in the clinical protocol including incidence, prevalence, and competing trials to assess the feasibility of the study plan. The role includes data driven analysis and site outreach for opportunities, participation in internal planning meetings, and collaboration with various stakeholders to gather feasibility information. You will also present feasibility analysis and engage with patient advocacy groups.

The Contracts Manager will review, draft, negotiate, and track a variety of legal agreements, working closely with the Clinical Operations study team to ensure deliverables align with study timelines and resolving contractual issues with stakeholders.

Responsible for the delivery of site activation readiness and mitigating any risks. Preparation of Clinical Trial Application Forms and submission dossier for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to requirements. Interaction with CA/EC for study purposes and handling responses to the CA/EC. Maintenance of project plans, project trackers and regulatory intelligence tools. Partner with the assigned site CRA to ensure alignment in communication and secure site review and manage collection of essential documents required for site activation/IMP release.

Provides leadership to the Clinical Operations Department across countries and ensures the delivery of high quality, timely and cost-effective clinical trial operations. Collaborates with executive management on the ongoing development of the Clinical Operations Department and contributes to the business plan at both the tactical and strategic levels.

Provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ensuring timely preparation of well organized, quality regulatory submissions in compliance with applicable regulations. Coordinates and prepares regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, as applicable.

Monitor and own the progress of clinical studies at investigative sites ensuring studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards. Coordinate activities to set up and monitor a study and Senior CRAs handle clinical trials and support Project Managers with trials that are larger in scope.

Monitor and own the progress of clinical studies at investigative sites and ensure studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards. Coordinate activities required to set up and monitor a study. Work with 2-3 protocols on average and support Project Managers with trials. Interact with clients, initiate payments, and participate in proposal activities.

The Senior Director, Clinical Business Development, is responsible for planning and directing all of the marketing and sales activities of the company for an assigned area of responsibility and/or region. This position functions as the main point of contact for external clients and potential partners in the advancement of Precision for Medicine’s goals and business endeavors.

The Project Manager plans, directs, coordinates, and delivers activities for designated clinical study projects to ensure that project objectives of quality, scope, cost, and time are accomplished. This PM will manage regional trials (moderate complexity) or provide support in managing complex global trials, serving as a primary point-of-contact and escalation point to the client.

Responsible for delivery of site activation readiness, preparation of Clinical Trial Application Forms, and interaction with CA/EC for study purposes. Providing updates about submissions, maintaining project plans, and customizing Patient Information Sheets. Act as SME for collection and maintenance of site level critical path to Site Activation data points. May support the clinical team performing Pre-Study Site Visits.

In this pivotal role you will have full service oversight for clinical projects across global/regional (ph I-IV) trials, within Oncology (or Rare Diseases or CNS). Accountable for clinical project delivery, oversight of all functional departments, and ensuring agreed timelines, scope, cost and quality, involved in all study stages. You will work in a cross-functional team with both internal and external stakeholders, driving quality.

The Senior Administration Assistant is responsible for providing administrative support to primarily for members of the executive team, which may include maintaining calendars, coordinating meetings/schedules, travel, meeting minutes, developing presentations, and various projects. Working closely with the Executive Team, the Sr Admin Assistant handles projects and assignments requiring problem solving skills, and in-depth knowledge of the leaders’ functions, programs, ongoing activities and priorities.