Digital Study Lead - Clinical Operations

TOP 5 Must Haves:

1. Understanding of the clinical operations (All Phases)
2. Experience with set up and implementation of clinical studies.
3. Experience with digital solutions set up and implementations in clinical studies (eConsent, patient reported outcomes and clinician reported outcomes, eDiaries and, processes)
4. Experience with User Acceptance Testing in clinical studies.
5. Project management experience

Support Human Centric Health (HcH) program by driving and implementing more unified digital trials platform solutions (ie: eConsent, ePRO, eClinRO, Televisits, etc...) within the context of clinical studies.
Within the global IT organization, the Digital Clinical Solutions Team is playing a crucial role in the Human Centric Health (HcH) program, by implementing digital solutions that educate, empower, and enable all to actively participate in clinical research and benefit throughout one s health journey. This is a real, progressive paradigm shift in the industry where we are driving disruptive transformation of how clinical trials are conducted. We are looking for someone to join us in our commitment to bring digital solutions to Clinical Development where we strive to better engage and help patients through their journey in treating their disease.

Patient Value through implementation of technology, strong influencing and collaboration with clinical study teams.
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 study specific configurations within the context of the product capabilities offered.
Ultimate responsibility for the delivery of the technology products within the technology 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 Digital Trial App products for the study. Accountable for all or any combination of:
Defining the functional Product 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 Digital Trials platform suite.
As needed: attend and provide training of the Digital Trials Platform product at Investigator meetings.
Accountable for the overall packaging of patient content for IRB/EC Submissions.
Works with CRO and Study Team members to ensure facilitation of the study requirements into the overall design.
Work with appropriate vendors to ensure proper eCOA translations & validation has been completed
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 IT governance rules and overall strategy.


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.
Previous/Current experience with Veeva products
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 doesn t 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.