Digital Clinical Operations Lead
Enable the client's Technology Transformation Implementation by enabling clinical studies with the client's product suite.
Patient Value through implementation of technology and strong influencing, collaboration
* Responsible for understanding the specific study requirements (software, devices, etc) associated with a given protocol design. This includes functional and non-functional requirements.
* The ability to translate these requirements into user stories for the Product Owner as needed.
* Ultimate accountability for the delivery of the technology of the client's suite for clinical studies.
* Full awareness of the clinical study pipeline, connecting with clinical study teams.
* Connects with each study team early during the planning phase and or studies that are under consideration.
* Deliver the client's study app for the study. Accountable for all or any combination of:
* Defining the functional scope of the app (which eCOAs, what patient experience, UX, other features part of the product(s)) in collaboration with study team or other cross functional teams supporting the study.
* Developing the overall study configuration and executing the overall study design within the client's suite.
* Attend and provide training of the client's product at Investigator meetings.
* Accountable for the overall packaging of patient content for IRB/EC Submissions.
* Works with CRO to ensure facilitation of the study requirements into the overall design.
* Work with appropriate vendors to ensure proper eCOA translations & validation has been completed, if not engage with Product Owner.
* Project planning: communicate any changes in recruitment planning to the client's squads and the Support, Logistics Run teams.
* Assists with the overall support and device enablement with the overall Launch, Run, Support lead to ensure proper and timely enablement of the team.
* Provide 2nd level support - supporting internal and external study teams during startup and maintenance phases of a study.
* Provide how to use support to study sites.
* Must be able to influence and collaborate with key stakeholders across the organization with a wide range of seniority to influence and credibly communicate your vision to bring people along with you in the journey (change agent).
* Influence stakeholders to embrace the strategy.
* Ensures that the systems are compliant with authoritative regulations, and aligned with the client's IT governance rules and overall strategy. Includes drafting/reviewing validation plans, configuration specifications, and support qualification testing.
EXPERIENCE
6+ years experience in Clinical Trial Technical Operations/Implementation roles in the pharmaceutical industry in clinical development.
Experience with new technologies in clinical development as it relates to study conduct.
Ability to present and speak in front of large audiences.
Influence stakeholders to drive ideation through execution.
Broad understanding of Clinical Development and ability to lead and drive execution.
Personality: as a person you can recognize yourself in the following statements:
* curiosity is how you learn
* status quo is not an option for you
* collaborating in an open networked environment gives you positive energy
* uncertainty/ambiguity doesnt stifle you
* winning is why you play the game
* no challenge is too big for you
Competences:
* Influencing / Commercial thinking / Analytical thinking / Solution-oriented thinking / Empathic /
Collaborative / Result-oriented / Innovative / Sense of responsibility / Decisiveness / Proactivity and
initiative / Optimism
Experience in system validation in a pharmaceutical, drug development environment.
Project Management skills (Project Planning, Status reporting/tracking, cost estimates)
Ability to travel to investigator meetings at 10% of time.
Physical Work Location: US Raleigh
Interested candidates please send resume in Word format to Please reference job code 72577 when responding to this ad.
GDH Consulting, Inc. 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.
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