Global Project Manager

Open Health

Global Project Manager

About OPEN Health

OPEN Health is a family of expert practices, working in partnership to drive positive change in healthcare communications and market access.
 
Founded in 2011, OPEN Health is structured as three specialist practices, all operating under the OPEN Health brand.
  • OPEN Health Medical Communications focused on medical affairs consultancy and content, publications planning and execution, multi-channel medical education and internal training
  • OPEN Health Patient & Brand Communications - focused on PR, advertising and patient engagement
  • OPEN VIE and Pharmerit – focused on HEOR, RWE and Market Access
Collaboration and connectivity was a founding philosophy and will continue to be a key driver for OPEN Health providing value for our clients and also offering an environment in which our employees can continue to thrive.
We have 15 offices across 6 different countries: US, UK, The Netherlands, Germany, India and China, with over 700 employees. OPEN Health works with 90% of the world’s top 40 pharmaceutical companies, across a broad client base including biotechnology and medical devices. Our therapeutic range is broad, with particular strength and focus on oncology, rare diseases and specialist medicines.
 
About OPEN VIE Value, Informatics & Evidence - bringing value to life
 
OPEN VIE believes that a compelling value strategy, supported by a robust and appropriate evidence base, should be at the heart of all activities to optimize patient access to life-changing healthcare interventions. We work in partnership with the life-sciences industry in the development and delivery of robust product value strategies throughout the product life cycle at a UK, EU and Global level.
 
Our offerings incorporate real world evidence, data analytics and value communications to support our clients in securing reimbursement and optimal commercialization of their assets. Our high-calibre, experienced team provides the full range of market access and real-world evidence services to ensure patient access to our clients’ new drugs and devices.
 
Our specialisms include:
  • Market access
  • Health informatics
  • Real world evidence
  • Patient centred outcomes (PCO)
Real World Evidence (RWE):
Recognised as a leader in the real world evidence arena for nearly twenty years, we work in strategic partnership with the pharmaceutical industry, healthcare and academia on RWE projects that drive improvement in healthcare delivery.
 
You will love this role if you:
  • Anticipate and understand the challenges of large scale, cross-functional project management
  • Work collaboratively in a fast-growing team, all dedicated to project delivery.
  • Are accomplished in leading a cross-functional team to perform to their full potential and deliver a project of the highest possible quality
  • Thrive in a busy, exciting and fast-paced environment
  • Take pride in your work and in building long-term relationships with clients and within and across the OPEN Health group of practices
  • Share our belief in and actively foster an environment where individuals are encouraged to develop through participating in training programmes aligned to personal development plans
 
You will be a success if you:
  • Strong demonstrable experience either as a CRA or Project Manager, with experience of managing a cross-functional team from project contract and start-up to final deliverables. Ideally, the GPM will have international study experience, in order to manage international RWE projects
  • Excellent client management skills
  • Working knowledge of Good Clinical Practice/International Council on Harmonisation (ICH) Guidelines and other applicable regulatory requirements
  • Comprehensive knowledge of the regulatory approval process for non-interventional research studies and general oversight of processes outside of UK
As part of the OPEN VIE team, you’ll be responsible for the following activities:
 
To project manage the implementation of real-world data collection projects for pharmaceutical industry clients, in UK, EU and international settings, in accordance with company policies, procedures and SOPs. More specifically, the role will involve client and project management and oversight of high-quality study delivery for projects across countries.  Managing projects to completion within contracted timelines and to the budget will be a critical success factor.
 
Primary responsibilities:
  • Financial management and operational project delivery of global and UK studies: to ensure project delivery is on time and within budget, from start to completion of all contracted activities
  • To develop strong and effective working relationships with clients and international partners to ensure understanding of objectives and timelines
  • Perform as the primary point of contact for the client from project start, once contract is signed and project handover has occurred from the RWE consultant, through to completion of all contracted services
  • To provide strong leadership of cross-functional teams to support efficient and effective project management, to meet project deliverables. The cross-functional team may include; Real World Evidence (RWE) Consultants, Patient Centered Outcomes Consultants, local country CRAs or Site Engagement Managers, and Project Managers/CRAs in partner organisations, Data Analysts, Data Managers and Scientific Consultants
  • To identify and quickly act to address out of scope activities and scope creep
  • To ensure the project team has project specific training as required
  • To ensure project meets required quality standards
  • Manage project staff from partner companies in other countries, or third-party vendors.  This will include project specific scoping and contracting with partners and vendors, in liaison with the Director of Project Management
  • To provide support and leadership to international CRA teams throughout projects, with regards protocol, therapeutic area, study procedures and SOP training
  • To manage and track financial information for all countries, in international projects
  • To ensure project delivery standardization and consistency across countries
  • To keep oversight of local country teams to obtain appropriate ethics and any other relevant approvals and negotiation of local hospital contracts
  • To oversee set-up, and thereafter ensure maintenance of, central and local country project files
  • To track project activities and provide regular communication to clients and project teams using CTMS if appropriate
  • To work with the relevant team members to develop data collection and communication guidelines to ensure consistency between researchers working on projects to enable effective data cleaning process
  • To ensure client sign off/agreement to final deliverable(s) is on file
  • To organise and drive project review meeting(s), accompanied by the RWE Consultant where relevant, to review project success factors
  • To use a thorough understanding of both the current healthcare research environment and the commercial objectives of our clients to proactively drive real world evidence projects
  • To maintain a commercial focus at all times, anticipating and troubleshooting barriers to project delivery, acting on them quickly to keep projects on track
  • To support growth of the business through excellence in project delivery and strong client relationships
  • Maintain thorough working records of all project activities, complying with company SOPs and GDPR requirements
 
Additional responsibilities:
  • Support the business development process by assisting with preparation for and active participation at bid defence and pitch meetings for new business opportunities
  • Identify areas for process improvements and support with the refinement of international standard operating procedures and working documents as required
  • Attend regular project management team meetings to facilitate a collaborative approach to all projects and provide peer guidance and support for global study roll out
  • Identify opportunities for new projects or project extensions and inform the Director of RWE/RWE Consultant of new business opportunities
What you’ll bring:
  • Bachelor’s degree or Registered Nurse (RN) in a related field, or equivalent combination of education, training and experience
  • Strong demonstrable experience either as a CRA or Project Manager, with experience of managing a cross-functional team from project contract and start-up to final deliverables. Ideally, the GPM will have international study experience, in order to manage international RWE projects
  • Excellent client management skills
  • Demonstrable budget management and finance skills
  • Working knowledge of Good Clinical Practice/International Council on Harmonisation (ICH) Guidelines and other applicable regulatory requirements
  • Comprehensive knowledge of the regulatory approval process for non-interventional research studies and general oversight of processes outside of UK
Skills, Qualities & Requirements:
  • Excellent organizational, verbal and written communication skills
  • Proven track record of excellent client management skills
  • Proactive, innovative problem-solving skills
  • Demonstration of a flexible attitude and ability to self-motivate
  • A conscientious ability to drive projects independently, with strong attention to detail
  • Ability to lead successful teams, mentor CRAs and deliver project-related training
  • Willingness to do occasional international travel
  • IT literate – working knowledge of Word, Excel and PowerPoint
  • Fluent in written/spoken English
What we offer:
 
At OPEN Health, we are entirely dependent upon our people. They are the basis of every contract we win, every service we provide and every project we deliver. As a result, we are always on the lookout for the brightest, most enthusiastic, creative and ambitious individuals to join our teams in the UK. We work hard to create friendly and collaborative workplaces; to provide fascinating professional challenges and amazing opportunities.
We have an extensive benefits package that includes:
  • A total of 29 days holidays – 25 plus an additional 3 at our Christmas shutdown plus your birthday off
  • Flexible start and finish times around core office hours
  • 4 pm Friday finish
  • A training platform that provides access to self-paced and face-to-face learning & development
  • Group Income Protection
  • Private Medical Insurance
  • Employee Assistance Programme
  • Life Assurance
  • Enhanced parental leave
  • Casual dress code
  • Active CSR community supporting a range of worthwhile causes