Team Lead, eCOA Solutions Design

Are you passionate about delivering high-quality solutions design consultation to pharmaceutical and biotechnology clients?

Clario is looking for a dedicated Team Lead to join our eCOA Solutions Design team in India. In this role, you will work closely with project teams and interface with clients and Clario solutions delivery leadership to ensure clinical protocols are efficiently and accurately mapped to software solutions within project scope. As a Team Lead, you will serve as an escalation point for study-related issues, assist in project allocations, utilization, and productivity, and take on supervisory responsibilities. If you thrive in a collaborative environment and are committed to excellence, we want to hear from you!

What we offer

• Competitive compensation (fixed + variable)

• Attractive benefits (security, flexibility, support and well-being)

• Engaging employee programs

• Technology for hybrid working and great onsite facilities

What you'll be doing

• Support the performance review process by providing applicable feedback to Solutions Design management, Conducts one on one bi-weekly meetings with Solutions Design Analyst team to discuss project status, issues, and issue resolution strategies

• Formally summarizes and responds to audit observations, and ensure implementation of any Corrective and Preventative Actions

• Functions as a subject matter expert to advise on internal devices and system functionalities, acting as a resource and mentor for other SD team members

• Functions as a subject matter expert to advise internal and external clients on design processes, specification design, and requirement gathering best practices

• Serves as escalation point on Study Related Issues

• Coordinates the overall Solutions Design Process ensuring that clinical protocols are appropriately mapped to software solutions efficiently, accurately and within project scope

• Creates and maintains specifications for study-specific implementations of Clario products and services using a Documentation Management System

• Ensures consistency between trial data capture, data delivery and database structures to meet client requirements

• Is responsible for the overall management of the Design Process including communication of design requirements internally and externally with the Customer. This includes participation in internal and external design milestone meetings

• Collaborates with Clinical Systems Translation & Licensing (CSTL) to confirm correct versions of copyrighted questionnaires are implemented

• Supports Solutions Validation/Quality Control testing by addressing any defects associated with the design in a timely manner

• Collaborates with other departments to investigate study issues found beyond the start-up phase of the study

• Collaborates with DM to ensure that the software solution captures the necessary data points for data extraction and that the Data Management Plan supports the software solution

• Assists in project scoping and change control processes including revision management

• Provides Estimates on new product initiatives, Assists in the evaluation of new product features

• Provides feedback with regard to product functionality and shares with Product Development group. Collaborates with R&D, Design, Innovation (design custom controls)

• Contributes to developing new core product offerings, and advising on improving existing devices

• Provides input to interdepartmental process improvement initiatives

• Coordinates the training of new team members on all aspects of the design process and standard practices and ensures these practices are consistently implemented across the group

• Performs Process Evaluation and leads internal projects to develop best practices

• Assists and advises on process Documentation, SOP, and Work Instructions related to departmental deliverables

• Tracks and evaluates trends in issues, CAPAs and project health to advise training topics

• Assists/Supports in the training of the SD staff on standard practices and ensures these practices are consistently implemented across the group

• Supports Solutions Design Delegate in audit preparation by researching project specific or process standards information as needed to evaluate or respond to audit findings

• Manages Solutions Design project allocations and resource assignments, utilization and productivity

• Assists management in monitoring and ensuring that design milestones are met on time across the department

• Reviews and analyzes proposals and protocols as needed, oversee and approve new study quotations

• Assists in the coordination of project allocations, utilization, productivity, and approval of timecards

• Completes activities in the Training Management System in a timely manner

• Tracks time for billable study related and non billable tasks in a timely manner

• Tracks SDA milestone start and completion dates using the Clario project scheduling tool

• Represents Solutions Design in sales inquiries describing the design function and best practices

• Collaborates with senior leadership counterparts from other Departments

• Serves as additional delegate representing Solutions Design in client audits to describe process flows, standards and best practices

• Assists management conduct interviews for hiring SDAs

• Leads internal SD team meetings as needed

• Participates in bid defense preparations when required

• May perform the role of Squad Leader of a cross functional team within Solutions Delivery made up of 12-15 employees working on assigned studies. Coordinates the solutions development process among team members ensuring that customer commitments, timelines and quality standards are met

• Collaborates with Sales and Science teams to act as a Subject Matter Expert on Devices, Device Functionality, Study Designs and Modalities to support new study quotations where appropriate

• Performs other duties as directed by Solutions Design Management

What we're looking for

• BS, BA or equivalent (in science/health care-related field a plus)

• Previous experience working with with eCOA / ePRO, IRT/RTSM, eConsent, or other eClinical / Clinical / Healthcare technology solutions is highly desirable

• Minimum of 8 years of total relevant experience

• Minimum of 5 years of Clinical Indication Specific experience

• Minimum of 3 years of Sponsor Specific Standards experience

• Demonstrated ability to mentor and lead a team

• Ability to understand and interpret clinical trial documentation such as protocols, questionnaires and other data collection instruments, and clinical data models

• Demonstrated experience in interpretation of client requirements to prepare and document design specifications

• Proven experience in client relations and interactions with clients at all levels

• Familiarity with FDA regulatory processes, clinical research processes

• Self directed - comfortable working in a fast-paced environment

• Ability to manage multiple project tasks and deliverables

• Proven problem-solving skills and attention to detail

• Excellent presentation, communication (written and oral) and negotiation skills

At Clario, we put people first, always. We are united and driven by patients, committed to making a difference, and we are always looking for the best talent to help us transform lives. We value the contribution each of our people brings. It’s only through our people that we can continue to innovate technology that will shape the future of clinical trials.