GCSO Innovation Manager
Gdh Consulting, Inc.

Job Info

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About GDH:
At GDH, we believe in the power of people and the importance of caring. Our culture statement, "We care about people," isn't just a tagline - it's the core of everything we do. GDH is a premier staffing and talent solutions company dedicated to helping businesses find the best talent and assisting job seekers in finding their dream jobs.

Who We Are:
GDH, founded in 2001, has grown into a leader in providing staffing solutions across various industries. We specialize in IT across several sectors, connecting top talent with leading enterprises. As a Best of Staffing firm recognized for excellence in client, employee, talent, and women's services, we pride ourselves on our commitment to quality and service.

Benefits of Working for GDH:

• Professional Development
• Competitive pay
• Full health insurance
• 401k Plan
• Holiday Pay
• Gym Membership Reimbursement
• Weekly Paycheck & Direct Deposit
• & More!

Job Description:
GDH is hiring a GCSO Innovation Manager to work with our client. 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 scope is global.

Major Accountabilities:

• 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
• 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
• Collect surveys related to the use of new solutions and lessons learnt
• Conduct frequent and timely communication of project progress to all stakeholders and ensure alignment of goals
• Prepare the organization for the change management on new initiatives in clinical studies and create an awareness campaign to support the implementation
• Support GCSO Innovation Leads on Digital Transformation projects and implement/pilot new solutions
• 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.)
• Educate & collaborate with Development Solutions, Patient Value Practice and other key stakeholders on knowledge sharing and inform on GCSO innovative solutions
• Work with strategic partners to ensure alignment on systems and processes for implementing new vendors or capabilities
• Build and ensure a high level of internal collaboration and alignment across key stakeholders, as well as with Strategic Partners
• Ensure best industry practices and high-quality deliverables consistent with all applicable guidelines and regulations
• As a member of the GCSO Innovation team and within the Clinical Data & Innovation
• Participate in team meetings by advising and supporting the line manager on strategic and operational issues related to GCSO Innovation, CDI, and GCSO
• Collaborate on daily basis with GCSO Innovation team, GCSO, PVUs, IT, and other
• relevant interfaces, including strategic partners, to ensure integration of activities and identification of areas for improvement
• Collaborate across Development / Medical Patient Value Practice, GCSO, PDL, CPM, IT, and relevant business units and maintain effective working relationships with interfacing groups
• Support efficient and effective communication and information exchange across Development Solution, Patient Value Practice, GCSO, IT, and other stakeholders
• Support activities that provide operational structure for GCPM and PDL such as:
• Budget planning and management
• Resource planning and management
• Policy and procedures development and maintenance
• SOP review and update activities

Knowledge Management and Training:

• Ensure that all company SOPs are adhered to and country regulations and GCP guidelines are followed with respect to site selection and engagement
• 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 ADL/SDL/CDS and provide input to processes on data standards and acquisition for new digital solutions
• Align with RML on protocol complexity to prioritize, explore, and implement digital and/or remote assessment including primary and secondary endpoints
• Travel as required
• Bachelor's Degree Required

Experience:

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

Specific Skills/Competences:

• Self-starter ready with the ability to lead large and small global, cross functional teams
• Inspire, persuade, influence and gain others support for ideas and actions
• Change management expertise including the ability to deliver training
• Ability to plan and prioritize goals to guarantee that deadlines are met
• Strong decision-making skills, results oriented and outcomes focused
• Ability to analyze, synthesize, and clearly present information to individuals and groups
• Ability to work in networks and matrix organization
• 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

Problem Solving:

• Lead and adapt to change with the ability to work independently, solve problems at all levels of difficulty, or uniqueness
• Ability to manage conflict and achieve consensus in a group through complex and thorough discussion
• 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

GDH provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, genetic information, veteran's status or any other category protected by law. In addition to federal law requirements, GDH Consulting, Inc. complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities and/or employees. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, benefits and training. Applicants with disabilities that require an accommodation or assistance in applying and/or for interviewing, please contact our HR Department.

Please visit our notice of collection for California applicants.

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