Clinical Trial Large Program Delivery Director Apply
Clinical Trial Large Program Delivery Director
San Francisco, CA
San Francisco, CA
Ideal Candidate
Reporting to the Delivery Head, the person will be driving Large Program/s under LSH domain that involves Device, Platform, Application, Hosting and Operations services. The person should be able to provide a single face to the internal and external stakeholders integrating multiple streams of execution. To provide focus and direction to the program delivery for meeting the strategic intent and satisfaction of the stakeholders. Should be able to size, estimate, plan, track and coordinate activities across different specialized teams and will be responsible for the delivery of the project, ensuring the financial targets are met and the customer satisfaction is maintained. Should have a strong background on delivering multiple small and large development, support and maintenance engagements. Should have experience in managing cross functional teams of around 80-100 people. The person has to be proficient in managing programs with multiple sprint teams and experience in working in Agile/SaFe Agile methodology and good experience with Agile tools.
Roles & Responsibility
To focus on relationship management with the concerned stakeholders and provide the necessary synergy to ensure alignment with the program delivery.
Overall responsibility for meeting agreed-upon deliverables, timeframes and quality metrics for the project for scope of work
Setting up and enforcing GxP practices on Program management which will be followed by different teams on the program across geographies.
To lead efforts in driving the program implementation and ensuring that all roadblocks are tracked and removed for smooth program delivery.
To hold custody of entire program and anchor Senior Management discussions with all key Stakeholders.
To conceptualize and ensure implementation of activities to achieve a high consumer satisfaction score
Knowledge on Cloud Platform AWS & DevSec Ops
To strategize and ensure creation of mechanisms, processes, etc. to enable the delivery of program across various time zones
Provide guidance to Program Managers and Scrum Masters on Sprint Planning, Story grooming and sprint team tracking and management.
Work closely with cross functional teams and Technical & Domain experts
Coordinate team reviews for each project milestone
Ensure that all Policies, Plans, Standards etc. are disseminated to the project team members & related groups
Status and performance reporting for the Program.
Resolution of Program issues and address Program/Project risks
To ensure local statutory compliances
Escalation of issues to senior management for speedy resolution
Track and coordinate knowledge and training needs of team
Manage requirements and ensure appropriate change management processes are implemented
Focus on improving productivity of the team and ensuring timely delivery of the requirements
Implementing quality control and assurance practices to be followed by the Program team
Ensuring an integrated Program plan including activities from various teams and project plans.
Works with partners to get required support in delivering the project
Identify the training needs of the team and ensure that the team is equipped with the necessary knowledge to deliver the project
Meets financial objectives by preparing project budget; tracking expenditures; analyzing variances; initiating corrective actions.
Updates job knowledge by participating in educational opportunities; reading professional publications
Accomplishes human resource objectives by recruiting, selecting, orienting, training, assigning, scheduling, coaching employees; communicating job expectations;
Desired Skills & Experience:
LSH domain background with virtual clinical trial exp.
Experience of delivering large VCT platform, Greenfield development and Support/Maintenance projects for Customers with Globally distributed teams across Geographies.
Program Management, Project Management, Service Integration and Service Management Skills.
Customer Management
Stakeholder Management
Escalation Management
Experience in delivering multiple new development and support/maintenance projects in the area of cloud / migration/transformation.
Financial management Experience in ensuring Program profitability goals of the Program being delivered
Preferably certifications in PMI - PgMP/PMP, ITIL and Agile - Scrum Master/SAFe .
Experience of delivering large VCT platform, Greenfield development and Support/Maintenance projects for Customers with Globally distributed teams across Geographies.
Program Management, Project Management, Service Integration and Service Management Skills.
Customer Management
Stakeholder Management
Escalation Management
Experience in delivering multiple new development and support/maintenance projects in the area of cloud / migration/transformation.
Financial management Experience in ensuring Program profitability goals of the Program being delivered
Preferably certifications in PMI - PgMP/PMP, ITIL and Agile - Scrum Master/SAFe .
Leadership Skills:
Stakeholder management skills required
Change management experience
Strategic influencing skills
Organizational awareness and networking skills
Stakeholder management skills required
Change management experience
Strategic influencing skills
Organizational awareness and networking skills
Essential Skills:
15+ years of direct experience in developing/managing solutions and building services for Healthcare/Pharma specific Clinical Solutions, in particular, in the areas of HIE, EHR/EMR, Healthcare Informatics, Telehealth, Mobile Health, EDC, safety systems, Healthcare Security, Pharma Informatics and corresponding Business Model development.
10+ years of direct experience in Pharma clinical development process with regards to protocol development, Clinical workflow design, project planning, randomization, blinding/un-blinding, clinical trial setup and data collection, clinical data management, safety monitoring & reporting and submission to global Health Authorities.
In-depth understanding and working knowledge of various top tier Pharma and Healthcare systems particularly, Medidata Rave, OC/RDC, Argus, various CTMS systems including Veeva Vault, ERM systems such as Epic, CERNER, Allscripts etc.
Hands on experience on data integration between Pharma systems including various CTMS, eTMF & CDMS, integration with lab systems & integration with various Healthcare systems.
Extensive hands-on experience as a technical lead as part of a complex software enterprise product development working on architecture, design and implementation.
Domain expert in software engineering quality management system (QMS)
Scaled Agile Framework (SAFe) experience is preferred
Experience in data extraction, ingestion, validation from medical devices into cloud environments (AWS, GCP, MS Azure, etc.)
Hands-on RESTful & Web API development
Working knowledge of HL7, FHIR, JSON, XML, CSV data formats
Lead risk management process including the identification and mitigation of failure models (FMEAs)
Partner across multiple operating segments including Application Development and Cybersecurity to realize the IoT vision
Build and roll-out design processes to SCRUM teams
15+ years of direct experience in developing/managing solutions and building services for Healthcare/Pharma specific Clinical Solutions, in particular, in the areas of HIE, EHR/EMR, Healthcare Informatics, Telehealth, Mobile Health, EDC, safety systems, Healthcare Security, Pharma Informatics and corresponding Business Model development.
10+ years of direct experience in Pharma clinical development process with regards to protocol development, Clinical workflow design, project planning, randomization, blinding/un-blinding, clinical trial setup and data collection, clinical data management, safety monitoring & reporting and submission to global Health Authorities.
In-depth understanding and working knowledge of various top tier Pharma and Healthcare systems particularly, Medidata Rave, OC/RDC, Argus, various CTMS systems including Veeva Vault, ERM systems such as Epic, CERNER, Allscripts etc.
Hands on experience on data integration between Pharma systems including various CTMS, eTMF & CDMS, integration with lab systems & integration with various Healthcare systems.
Extensive hands-on experience as a technical lead as part of a complex software enterprise product development working on architecture, design and implementation.
Domain expert in software engineering quality management system (QMS)
Scaled Agile Framework (SAFe) experience is preferred
Experience in data extraction, ingestion, validation from medical devices into cloud environments (AWS, GCP, MS Azure, etc.)
Hands-on RESTful & Web API development
Working knowledge of HL7, FHIR, JSON, XML, CSV data formats
Lead risk management process including the identification and mitigation of failure models (FMEAs)
Partner across multiple operating segments including Application Development and Cybersecurity to realize the IoT vision
Build and roll-out design processes to SCRUM teams
Soft Skills:
Proven experience leading cross-functional teams to documented results.
Strong consultative and communication skills, interpersonal, analytical ability, decisiveness, and the ability to work effectively with external IT organizations and both internal and external clients.
Strong team building, organizational, planning, analytical and problem-solving skills.
Ability to translate market/customer needs into well-conceived, cost effective solutions
Formulate business cases for new product innovation and major enhancements
Assist the launch of new releases and products by working across the company to ensure a successful market launch, Support marketing organization with positioning & messaging content
Assist in continuous development of the innovation solutions used to evaluate, assess, and develop new product opportunities.
Proven experience leading cross-functional teams to documented results.
Strong consultative and communication skills, interpersonal, analytical ability, decisiveness, and the ability to work effectively with external IT organizations and both internal and external clients.
Strong team building, organizational, planning, analytical and problem-solving skills.
Ability to translate market/customer needs into well-conceived, cost effective solutions
Formulate business cases for new product innovation and major enhancements
Assist the launch of new releases and products by working across the company to ensure a successful market launch, Support marketing organization with positioning & messaging content
Assist in continuous development of the innovation solutions used to evaluate, assess, and develop new product opportunities.
