Clinical Operations Project Manager - Remote

Hi,

Job Title: Clinical Operations Project Manager - Remote

Job Location: Remote - EST

Job Duration: 12+ Months Contract

Pay Rate: $60/hr on w2 basis

Summary: Job Title: GCSO (Global Clinical Sciences and Operations) Innovation Manager

The primary function of this position is responsible for identifying and exploring new innovative solutions that could be implemented in clinical studies to be patient centric and supporting digital transformation projects by preparing for the implementation of scalable solutions working in partnership with internal and external stakeholders. The geographical Product is global.

Major Accountabilities: As the GCSO (Global Clinical Sciences and Operations) Innovation Manager:

• Prepare the organization for the change management on new initiatives in clinical studies and create an awareness campaign to support the implementation.
• As a member of the GCSO Innovation team and within the Clinical Data & Innovation
• Develop the framework and processes (including best practices) needed to successfully implement selected digital transformation solutions in clinical studies and provide the continuous support (light touch) throughout the study until closeout.
• Relevant interfaces, including strategic partners, to ensure integration of activities and identification of areas for improvement.
• Work with strategic partners to ensure alignment on systems and processes for implementing new vendors or capabilities.
• Educate & collaborate with Development Solutions, Patient Value Practice and other key stakeholders on knowledge sharing and inform on GCSO innovative solutions.
• Support activities that provide operational structure for GCPM and PDL such as:
• Collect surveys related to the use of new solutions and lessons learnt.
• Support efficient and effective communication and information exchange across Development Solution, Patient Value Practice, GCSO, IT, and other stakeholders
• Build and ensure a high level of internal collaboration and alignment across key stakeholders, as well as with Strategic Partners
• Conduct frequent and timely communication of project progress to all stakeholders and ensure alignment of goals.
• Collaborate across Development / Medical Patient Value Practice, GCSO, PDL, CPM, IT, and relevant business units and maintain effective working relationships with interfacing groups.
• Collaborate on daily basis with GCSO Innovation team, GCSO, PVUs, IT, and other.
• Build external networks of peers and providers to ensure company is at the forefront of new technologies and initiatives regarding clinical study innovation and participate on external work groups (e.g. Transcelerate, IMI, etc.)
• Ensure best industry practices and high-quality deliverables consistent with all applicable guidelines and regulations.
• Participate in team meetings by advising and supporting the line manager on strategic and operational issues related to GCSO Innovation, CDI, and GCSO
• Evaluate and assess new solutions (including digital) to be imbedded in clinical studies including but not limited to telemedicine, wearables/devices/sensors, eConsent, eCOA, and others to be implemented during the study concept design.
• Support GCSO Innovation Leads on Digital Transformation projects and implement/pilot new solutions.

o Budget planning and management

o Resource planning and management

o Policy and procedures development and maintenance

o SOP review and update activities

o Knowledge management and training

• Ensure that all SOPs are adhered to and country regulations and GCP guidelines are followed with respect to site selection and engagement.
• Align with ADL/SDL/CDS and provide input to processes on data standards and acquisition for new digital solutions.
• Collaborate with CSA to manage the scale up of the new technological solutions transitioning to company Enterprise, includes region/country implementation, testing, company support (if any), systems integration, product/system lifecycle
• Align with RML on protocol complexity to prioritise, explore, and implement digital and/or remote assessment including primary and secondary endpoints
• Travel as required

Bachelor's Degree Required

Experience

• Good understanding of Clinical Development process.
• Previous team leadership experience is preferred.
• Proven track record of successfully leading cross-functional projects in a global environment.
• A minimum of 3 years in project management.
• Good working knowledge of GCP guidelines in different regions
• A minimum of 2 years of experience implementing complex initiatives within a regulated matrix / partnership environment within the Pharmaceutical, Biotechnology, and/or CRO industry.

Specific skills/competences

• Ability to analyze, synthesize, and clearly present information to individuals and groups
• Clear and articulate verbal, written and presentation skills with excellent command of the English language
• High levels of initiative, drive and commitment, with an expert ability to adopt an entrepreneurial and innovative style
• Ability to work in networks and matrix organization
• Strong decision-making skills, results oriented and outcomes focused
• Self-starter ready with the ability to lead large and small global, cross functional teams
• Ability to plan and prioritize goals to guarantee that deadlines are met
• Change management expertise including the ability to deliver training
• Inspire, persuade, influence and Product others support for ideas and actions

Problem solving

• Ability to gather facts and data, to evaluate processes and situations in an orderly and rational manner, ask questions and identify missing information
• Ability to decipher complex problems/situations using valid reasoning and identify appropriate solutions
• Creative and develop cost-effective solutions in an effort to maximize efficiency and achieve success when confronted with limited resources
• Ability to manage conflict and achieve consensus in a group through complex and thorough discussion
• Lead and adapt to change with the ability to work independently, solve problems at all levels of difficulty, or uniqueness