Senior Project Manager (Clinical Trials) - US based

IXICO Description

IXICO’s mission is to improve brain health through the application of digital technologies. Established in 2004 and listed as a public company in October 2013, IXICO has firmly established itself as a trusted partner to the global biopharma industry, providing technology-enabled speciality services. Our neuroscience expertise in image data management and analysis provides specialist data analytics services used by the global Pharmaceutical industry to select patients for clinical trials, assess the safety and efficacy of new drugs in development and in post marketing surveillance. Our neurological disease focus includes Alzheimer's disease, Huntington's disease, Multiple Sclerosis and Parkinson's.

Our integrated product offering covers every stage of clinical drug development through to post marketing surveillance and we continue to invest in infrastructure and innovation to support our ambitious growth strategy. Our competitive advantage is our ability to improve the efficiency and value that our customers derive from collecting and analysing clinically meaningful, regulatory compliant data to make better informed decisions.

As the pharmaceutical industry looks to pave the way for personalised medicines, they will need to mine clinical trial and real-world data to tailor specific products to the individual patient. IXICO is uniquely positioned to deliver these approaches by further innovating, customising and scaling our integrated digital platform.

And our people make all this happen. We have a passionate, dedicated team, bringing together the essential skills needed to innovate and develop cutting-edge technologies, provide the support our customers need and enhance our service offering.

As we continue to grow we are looking to hire a Senior Project Manager (US based) to support us on a full-time basis. As IXICO is a UK based company with certain presence in the US this role will primarily work remotely.

Reporting into:

  • VP Programme Management

Purpose of the Role

The Senior Project Manager is responsibility for managing a portfolio of clinical trials and research/collaborative studies, providing oversight and direction to IXICO project team members for the full project life cycle for assigned projects. Projects will include those in start-up or complex delivery stages, in a variety of indications and trial phases, and will be with primarily USA based clients and sites. The Senior Project Manager is responsible for developing lasting relationships with IXICO’s sponsors.

This is a key role within the Operations Team ensuring successful delivery of IXICO’s projects, achieving targets and delivering continuous improvement. This position interfaces with other departments within IXICO and externally with sponsors, partners, sites and subcontractors and vendors.

The key deliverables for this role include:

  • Meeting contracted scope, revenue and budget targets for a portfolio of projects
  • Setting, monitoring and meeting key delivery metrics and KPIs
  • Planning resources and forecasting work activities
  • Managing subcontractors and vendors for project deliverables and logistics
  • Identifying areas of improvement and developing plans to address these areas
  • Support Business Development and input to new project proposals, attending bid defences and conferences as necessary

 Within each assigned project, the Senior Project Manager is responsible for:

  • Assessing proposed scope of work in a study proposal or change order can be delivered against desired sponsor timelines and against acceptable operating margin as set by IXICO leadership.
  • Operational sign-off for study or change order budgets and review/approval of Statement of Work before contract execution.
  • Functioning as the main point of contact for clients, imaging centers and vendors, throughout the project lifecycle from start-up through close-out.
  • Development and implementation of project plans and timelines via internal and external kick-off meetings ensuring agreement by all parties.
  • Development and delivery of presentations for investigator meetings and kick off meetings, as necessary.
  • Coordinating cross functional teams, including external 3rd parties/vendors when necessary, to ensure efficient delivery of all project requirements.
  • Provide project updates to clients on a regular basis, including conducting routine client calls and maintaining accurate meeting minutes.
  • Revenue forecasting, milestone and invoice tracking and coordinating budget updates.
  • Escalating issues to management, including delivery related risks, as appropriate and leading on timely resolution of CAPAs on assigned projects.
  • Meeting project management metrics on assigned projects, including quality, compliance, KPI and revenue objectives.
  • Ensuring project(s) audit/inspection readiness at all times.
  • Maintaining project documentation and ensuring compliance with SOPs and regulatory requirements.

 Requirements:

  • Degree level (preferably life sciences related) with strong academic performance or equivalent education or work experience.
  • Minimum desired 5 years of Project Management experience with a CRO/Technology service provider to the pharmaceutical clinical trials market with multiple projects of varying complexities across all project life-cycle phases.
  • Ability to review and report project performance verbally and written reports in line with agreed project KPI’s and other leading indicators.
  • Demonstrates an excellent understanding of clinical research phases, the processes involved in the planning and management of a clinical trial, and the application of these in day to day responsibilities in a regulated environment.
  • Demonstrated ability to provide deliverables accurately, on time and on budget across assigned projects.

Other:

  • Strong communication and interpersonal skills.
  • Proven independent and remote working abilities; whilst also knowing when and how to request support.
  • Proven track record of resolving conflict and managing competing priorities.
  • Must be highly organised and motivated with strong problem-solving skills.
  • Ability to establish and maintain effective professional relationships with co-workers and clients.
  • This role will require extensive collaboration between our staff in the United States and United Kingdom, as well as with Sponsors in countries worldwide. Consequently, meetings and calls may sometimes take place outside of standard work hours.
  • Demonstrated ability to present to audiences of seniority in-person (travel and social distancing requirements permitting) and remotely.
  • Proficient in the use of Microsoft Office software applications and in clinical data management systems.

 US Staff Benefits:

  • Competitive annual salary and eligibility tor the company’s annual bonus scheme
  • IXICO health, dental and vision benefits as well as 401K plan and workers comp
  • 20 days’ vacation per calendar year in addition to specific holidays, such as Labour Day, Easter, Xmas, etc.
  • A very sociable, supportive, and highly motivated team
  • A company in an industry where your work has an impact every single day

How to Apply

IXICO is working hard to create a representative, inclusive and super-friendly team, because we believe different experiences, perspectives and backgrounds make a better workplace, and ultimately better services.

IXICO provides equal employment opportunities to all employees and applicants for employment. IXICO doesn’t discriminate on the basis of race, colour, religion or belief, gender, national origin, age, sexual orientation, marital status, disability or any other protected class.

This is a great opportunity for a highly experienced clinical trials professional to thrive in an engaging and fast-paced environment, to make a difference on an every day basis. You will be given support to enable you to grow with your challenges, and we pride ourselves to be a sociable and diverse bunch of people, who are all working together on one big mission: Improving brain health. Will you join us?

If you think IXICO should meet you, please send us your CV and covering letter by email to careers@ixico.com. We are looking forward to your application!

Please note that IXICO will process the data provided by you only in order to perform the outlined recruitment exercise. For more details on what data we process and on what legal basis this happens please view our Recruitment Privacy Policy or contact careers@ixico.com.