24 Aug
|
Oncoshot India
|
Thane
24 Aug
Oncoshot India
Thane
1. Role Summary
We are seeking a permanent Clinical Lead – Projects and Platform (CLPP) to own the delivery of oncology data projects across Oncoshot’s federated hospital network. This role suits a medically trained professional with hands-on real-world evidence (RWE) experience who can translate sponsor requirements into executable delivery plans, run studies end-to-end across multiple sites, and convert delivery experience into improvements to the underlying data platform.
You will be accountable for project outcomes, sponsor-facing scientific delivery, and the progressive reduction of bespoke effort required to deliver each new study. The role reports to the CEO/Chief Medical Officer, works with the CCO on sponsor engagement, and works with the CTO and COO on platform and data-model requirements.
2. Key Responsibilities
- Own and lead the full project lifecycle: pre-award feasibility input, protocol and study design, data dictionary construction, extraction and curation, quality assurance, and delivery to the sponsor.
- Act as the scientific and delivery lead for commissioned RWE and registry projects; manage scope, timelines, risks, dependencies, and sponsor expectations.
- Author the study synopsis, protocol, and study data dictionary, and align the dictionary to the platform common data model (OS CDM), documenting variances.
- Define project success criteria and evaluation frameworks aligned to sponsor objectives and to the data available across participating sites.
- Coordinate extraction, curation, and audit activity across multiple participating centres and jurisdictions, working with site data and labelling teams who are not direct reports.
- Establish and enforce data quality processes, working within site-hosted secure environments where patient-level data does not leave the institution.
- Contribute manpower and effort estimates to pre-award budget tables, including assessment of CDM modification effort and QA burden.
- Produce and maintain project artefacts: project plan, site milestone tracker, weekly status reports, and decision and query logs.
- Ensure adherence to privacy, security,
and regulatory requirements across jurisdictions (for example PDPA and GDPR where applicable), and coordinate ethics and IRB submissions per site.
- Capture recurring delivery friction and convert it into a ranked, evidenced set of platform and data-model requirements for the CTO and CEO/Chief Medical Officer.
- Build reusable dictionary components, templates, and playbooks that reduce the effort required to scope and deliver future studies.
3. Required Qualifications & Experience
- Medical degree (MBBS, MD, or equivalent) is required.
- At least 1 year of clinical working experience.
- At least 3 years of hands-on experience delivering real-world evidence (RWE) or observational health data projects, ideally in oncology.
- Working command of OMOP CDM, including the practical work of mapping a study dictionary onto a common data model and documenting variances.
- Protocol and synopsis authorship, with sufficient statistical literacy to challenge an analysis plan rather than simply accept it.
- Experience coordinating delivery across multiple sites, including the ethics, data agreement, and stakeholder work this entails.
- Comfortable working within site-hosted secure environments where data cannot be exported, and able to run quality assurance under those conditions.
- Excellent communication skills, including the ability to hold a scientific position with a sponsor’s medical lead and to translate technical findings for non-technical stakeholders.
4. Preferred Qualifications
- Prior experience in a federated or distributed research network (for example EHDEN, OHDSI, or an equivalent consortium).
- Exposure to more than one national data environment, particularly Japan, India, or the Netherlands.
- External control arm design or health technology assessment (HTA) facing evidence work.
- Publication record in oncology real-world evidence.
- Comfort specifying requirements to an engineering team, including user story writing.
- Familiarity with health data standards beyond OMOP (for example FHIR, CDISC, ICD, SNOMED).
5. Core Competencies
• Scientific and Project Delivery: structured planning, execution discipline, and accountability for delivered data against specification.
• Data & RWE Design: ability to design studies and dictionaries, and to interpret data quality and completeness on real-world oncology datasets.
• Stakeholder Management: effective engagement across sponsors, site research offices, internal product and engineering teams, and clinical collaborators.
• Problem Solving: analytical thinking, hypothesis-driven troubleshooting, and decision-making under uncertainty and access constraints.
• Client Orientation: delivery ownership, credibility in sponsor discussions, and focus on outcomes.
• Documentation & Process Design: ability to build playbooks, reusable components, and scalable delivery practices.
6. Success Measures (First 3-month probation)
- Develop a project plan for the first assigned study, with clear objectives, milestones, and site-level accountabilities.
- Build the study data dictionary and map it to the platform CDM, documenting variances.
- Communicate the plan clearly to the sponsor and to internal teams, and track progress against it.
- Identify risks, assumptions, issues, and dependencies, and propose mitigation actions.
- Issue the first platform and data-model requirements observations to the CTO and CEO.
7. Working Model
- Permanent full-time position after passing the probation of 3 months.
- Hybrid work arrangement (subject to project and site requirements).
Occasional travel to sites in Singapore and overseas may be required, concentrated around site activation and audit windows.
8. Salary Range
- Indicative gross monthly salary:
- Excludes CPF for PR and Singaporeans, and excludes performance bonus and perks. An Employee Equity Share component is included; final package will commensurate with experience and seniority.
📌 Clinical Lead – Projects and Platform (CLPP) (Thane)
🏢 Oncoshot India
📍 Thane