ABOUT US

Simbec-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 ROLE

We are looking for a Senior Project Manager 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. It may include a dual role of managing the CRA team on some smaller studies where no Clinical Trial Lead is assigned. Studies managed will usually be "complex" or "non-complex" studies, with any number of participating countries or investigator sites.

You will work with other cross-functional service team leads (Clinical, Regulatory, Biometrics, Medical, Pharmacovigilance, Technical Writing, Laboratory, IMP Management, Contracts) and vendors, you will ensure clinical trials are conducted with optimal quality, on time and on budget such that subjects' rights, safety and well-being are protected and that the clinical trial data are reliable.

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 ACCOUNTABILITIES

• Acts 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.
• Lead and manage the cross-functional project team, which includes Clinical, Regulatory, Biometrics, Medical, Pharmacovigilance, Technical Writing, Laboratory, IMP Management and Contracts.
• Lead the CRA team on smaller studies where no Clinical Trial Lead has been assigned.
• Communicates 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.
• Develop appropriate study management plans in collaboration with service leads.
• Manage Project risks and resolve issues.
• Manage vendors who provide services in support of the projects (for example, IRT/RTSM, third party laboratories, meeting organisers). This includes identification of the vendors, obtaining quotes for the scope of their work and managing this work as per the agreed contract.
• Manage and report 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. At the Bid Defence meeting actively contributing to the discussions and presenting slides as agreed at the internal preparation meeting.
• Act as a "buddy" for new team members joining Simbec-Orion.

SKILLS REQUIRED

ESSENTIAL

• Degree or equivalent level qualification in life sciences / related area or equivalent combination of education, training and experience.
• Experience of managing several projects with a minimum of 3 services within a Clinical Research Organisation (CRO) or pharmaceutical industry.
• Global experience of managing Phase 1- III patient studies from set-up to close-out.
• Strong communication skills with the ability to present in Fluent English.
• In-depth knowledge of, and skill in applying ICH-GCP guidelines and any other applicable clinical research regulatory requirements.
• Experienced in using tools such as eTMF and CTMS.
• Good knowledge of project finances that includes revenue recognition and forecasting of professional fees.
• Highly motivated and able to work and plan independently and in a team environment.

DESIRABLE

• Intermediate experience (create a project, baseline a project, re-schedule the project, enter project progress) with MS Project or other Project Management software.
• Able to input into the strategy for new business.
• Ability to solve challenging problems balancing facts and logic, i.e. handling difficult requests or complaints.
• Experience in managing Rare & Orphan Disease clinical studies.
• Experience in managing early phase Oncology dose escalation clinical studies.
• Experience in managing adaptive design studies.

WHY YOU SHOULD JOIN US

Simbec-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.