Associate Project Director

ABOUT USSimbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers – headed up by a centralised leadership team.With a focus on tailormade and scalable solutions, we’ll adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients’ lives. THE ROLEWe are looking for an Associate Project Director to join our Project Management - Clinical Development team where you will have full project management responsibility for all aspects of phase I-IV patient clinical studies from start-up to close-out managed according to Simbec-Orion (and/or Sponsor) Standard Operating Procedures (SOPs), ICH-GCP and local regulations. Studies managed will usually be "complex" or "non-complex" studies, with any number of participating countries or investigator sites. You may work on a single large study or several studies as oversight with Project Manager’s (PMs) managing day to day tasks.You will provide support to Commercial Development to win new or repeat business by inputting into Requests for Proposals (RFP) based on experience of managing studies with the same Sponsor or similar studies as the RFP. KEY ACCOUNTABILITIESAct as the primary point-of-contact and liaison with the Sponsor to provide outstanding customer service and serves as an ambassador to promote Simbec-Orion’s high quality and ethical image.Provide oversight on large studies or several smaller studies with PMs managing day to day tasks or on directly managed studies, lead and manage the cross-functional project teams.Communicate with internal Department Heads and Senior Management to evaluate study needs, resources and timelines.Manage contractual project deliverables, agreed timelines, quality/scope and cost, including monitoring progress via metrics and when overseeing studies, manage in conjunction with the PMs.Develop appropriate study management plans in collaboration with service leads and Project Managers when overseeing studies.Manage risks on Projects and resolve issues on assigned studies or in conjunction with PMs when overseeing studies.Manage and identify vendors who may be providing services in support of the projects (for example, IRT/RTSM, third party laboratories, meeting organisers).Manage and reporting of project finances, including management of out of scope activities as per Simbec-Orion processes.Prepare presentation slides for Project Management aspects and co-ordinating delivery of presentation slides from the cross-functional project team for Bid Defence meetings. Act as a “buddy” for new team members joining Simbec-Orion.Act as a point of escalation for the Sponsor Project Manager when acting as oversight on studies. SKILLS REQUIREDESSENTIALDegree or equivalent level qualification in life sciences / related area or equivalent combination of education, training and experience.Experience of managing full service projects within a Clinical Research Organisation (CRO) or pharmaceutical industry.Global experience with managing Phase 1- III patient studies from set-up to close-out.Excellent communication and presenting skills in English.In depth knowledge of, and skill in applying ICH-GCP guidelines and any other applicable clinical research regulatory requirements.Fully experienced with using tools such as eTMF and CTMS.Expert knowledge of project finances that includes revenue recognition and forecasting of professional fees, pass through costs and Investigator fees.Highly motivated and able to work and plan independently and in a team environment.Ability to solve challenging problems balancing facts and logic.Able to input into strategy for RFPs.DESIRABLEExperience with overseeing projects or programmes.Intermediate experience (create a project, baseline a project, re-schedule the project, enter project progress) with MS Project or other Project Management software.Experience with mentoring and supporting junior project management staff.Experience with developing SOPs and input into department processes that may need improving.Experience in managing Rare & Orphan Disease clinical studies.Experience in managing early phase Oncology dose escalation clinical studies.Experience in adaptive design studies. WHY YOU SHOULD JOIN USSimbec-Orion is growing fast. To keep up with demand, we’re looking for the best people, from all areas of clinical development, to join our team.We’re dedicated to bringing the latest advances in science to market. Exposure to truly innovative new drugs in patient populations with serious unmet medical needs is what drives our company – and your reason to be a part of it.With experts from all disciplines under the same roof, you’ll work alongside some of the industry’s best. So if you’d like to further your career within challenging therapeutic areas in rare disease, oncology, or at our clinical pharmacology site, or laboratory services. We’re waiting to hear from you.
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