Clinical-Trial Evidence Platform Director — Rare Disease Research

The mandate

Two pivotal rare-disease studies will combine electronic clinical forms, central-laboratory assays, imaging, home nursing and continuous wearable endpoints, yet their source identities and correction paths differ by vendor. The current integration plan proves transfer, not whether a statistician can recreate the effective evidence used after site queries, device replacement, laboratory reruns and protocol amendments. Study start cannot absorb another platform experiment.

The named deliverable is a Clinical Evidence Platform Qualification Package covering patient and visit identity, source authority, event and effective time, lineage, query state, blinded correction, endpoint derivation, access and retention. It must include a reference implementation across six critical journeys, a validated-control strategy, vendor obligations and a costed deployment decision that works before first-patient-in.

Milestone one at week five provides evidence journeys, regulatory intended use and critical gaps. Week eleven concludes milestone two with target architecture, data contracts and validation plan. At week nineteen, milestone three supplies qualified reference journeys and failure-injection results. The accepted package, supplier schedules, operating playbook and study-readiness decision form milestone four at week twenty-six.

Acceptance requires Quality to trace three unseen endpoint values from analysis back through every transformation, correction and authorised source; Biostatistics must reproduce derived populations from retained versions; and Clinical Operations must resolve a simulated site-device identity conflict inside target. The two study executives sign only after internal staff perform the exercise without consultant interpretation and all critical vendor obligations are contracted.

The client will provide protocols, data-management plans, source agreements, sample records, transformation code, vendor specifications, validation standards and historical query cases in controlled environments. Site, laboratory, wearable and statistical owners will attend design and testing. Client validation staff execute formal approvals, while the development-operations chief resolves disputed ownership or supplier access within three business days.

Why this is external work

Clinical, statistical and technology teams each govern valid fragments of evidence, but none can independently arbitrate all supplier boundaries while preparing two trials. Current integrators benefit from expanding their platform footprint. An external clinical-data operator can impose end-to-end qualification without replacing sponsor accountability or making one vendor’s representation the scientific record.

What you will own

• Map consented participant, visit, sample, image, device, observation and endpoint identities through every supplier and authorised correction path.
• Define source authority, occurrence time, effective version, query status, blinding, provenance and retention contracts for six critical evidence journeys.
• Design validation that targets patient safety, endpoint interpretability and reproducibility rather than merely confirming successful file transfer.
• Exercise site merge, device replacement, laboratory rerun, late query, protocol amendment and blinded correction under realistic study conditions.
• Reconcile vendor and sponsor responsibilities for discrepancy, reprocessing, audit evidence, outage, exit and inspection retrieval.
• Produce a deployment decision connecting control sufficiency, enrolment timing, operating burden, supplier change and long-term study cost.
• Transfer qualification scripts, decision logs, exception governance and inspection rehearsal to named Quality and clinical-data owners.

Candidate qualifications

• Led clinical-data or evidence platforms for pivotal regulated studies involving multiple sites, laboratories and digital endpoint providers.
• Reconstructed patient-level endpoint lineage after queries, reruns, protocol change and blinded correction without compromising treatment masking.
• Designed computer-system validation around intended clinical and statistical use rather than generic technical requirements.
• Negotiated enforceable source, correction, audit, retention and exit obligations with clinical technology and laboratory suppliers.
• Prepared investigators, data managers and statisticians to reproduce evidence under inspection without dependence on the implementation vendor.
• Delivered a trial-ready operating model before enrolment while keeping sponsor Quality, medical and statistical accountability intact.

Non-negotiables

• The named director must lead Boston evidence workshops and attend qualification sessions with representative sites and vendors.
• No reseller, referral or contingent implementation economics may exist with clinical, laboratory, wearable or cloud platforms considered.
• Patient-level evidence must remain within approved controlled environments, with blinding and least-privilege rules preserved.
• Platform acceptance cannot be represented as medical, statistical or regulatory approval of either study or endpoint.

1. 49 words maximum. Describe a clinical endpoint whose lineage changed after a site query, laboratory rerun or device replacement.
2. 49 words maximum. How would you test effective-time evidence after a protocol amendment without compromising study blinding?
3. 49 words maximum. Which client inputs are indispensable before you can qualify a multisupplier evidence journey?