Clinical-Site Activation Recovery Leader

The mandate

An internal audit found sites classified active after system release even though local contracts, staff training, laboratory logistics, investigational-product custody or referral pathways remained incomplete. Country teams count milestones differently, vendors escalate late and first-patient forecasts no longer reconcile to usable capacity. The study-start executive left during corrective action. The interim takes global activation authority while investigators, ethics bodies, regulators, pharmacy and Quality retain their independent approvals.

The appointment begins within two weeks and runs nine months through two first-patient milestones, corrective-action closure and a permanent search starting in month three. The first twenty days establish one site state and protect any participant-facing activity. Months two through six repair country, vendor, supply and readiness routines across three studies. The final phase proves activation through unseen site cases and successor-led global reviews.

Handover is complete when the permanent leader has chaired six reviews, every selected site has a verified readiness state and next action, corrective actions have accepted evidence, and first-patient forecasts reconcile to country capacity. The successor inherits site and country archetypes, approval dependencies, contract and budget constraints, training, supply and laboratory risks, vendor obligations, forecast logic and a ninety-day permanent plan.

The interim may reject activation, reset milestones, reallocate start-up resources, replace temporary workstream leads, constrain vendors and commit approved remediation funds. Investigator selection, protocol design, ethics or regulatory approval, pharmacy release, quality acceptance, permanent senior appointments, site termination or spend above USD8 million needs authorised owners or committee approval. The interim cannot pressure independent bodies or reinterpret jurisdictional requirements.

Patient recruitment strategy, clinical data review, safety decisions, submission authorship and wholesale clinical-platform replacement are outside scope. The interim will not mark sites ready from document upload alone, bypass training or supply evidence, or improve forecast by excluding difficult countries. Work concerns truthful operational readiness and accountable handoff; clinical and regulatory judgments remain attributable.

Why this seat is open

Audit evidence showed that a critical development milestone had become a collection of incompatible local definitions. The leadership exit left three pivotal studies without one start-up authority. The sponsor needs a seasoned development operator who can make immediate stop and resource decisions, preserve independent approvals and leave a successor with a defensible global forecast.

What you will own

• Reconcile country, site, contract, approval, training, pharmacy, laboratory, supply and system states across three studies, including conditioned, expired and rejected readiness evidence by accountable owner.
• Decide operational activation and start-up resource allocation within delegated authority.
• Reset site-state definitions, evidence gates, exception clocks and forecast rules across countries and vendors.
• Establish readiness reviews that separate document receipt from accepted, usable participant-facing capability.
• Close corrective actions through sampled site journeys and independent Quality evidence.
• Exercise approval delay, kit failure, untrained replacement, pharmacy hold and system-access scenarios.
• Induct the permanent leader and transfer site, study, vendor and country risks.

Candidate qualifications

• Has held executive study-start authority across multinational pivotal clinical programmes with ethics, regulator, pharmacy, laboratory, supply, system, investigator and vendor dependencies under milestone pressure.
• Can evidence activation recovery where uploaded documents did not represent complete site readiness.
• Understands contracts, budgets, ethics, regulation, training, pharmacy, laboratories, supply and site systems.
• Has protected investigator, ethics, regulator and Quality independence under milestone pressure.
• Can distinguish selected, initiated, technically enabled, activation-approved and patient-ready sites.
• Has handed a corrective-action recovery to permanent leadership before first-patient milestones.

Non-negotiables

• Can start from Boston within two weeks and complete monthly country residencies.
• Will not design protocols, influence approvals, release product or make participant decisions.
• Brings direct global site-start authority; clinical technology or monitoring experience alone is insufficient.
• Will preserve delayed, conditioned and rejected sites in portfolio forecast evidence.

1. 49 words maximum. Which site-activation state most seriously overstated readiness in a programme you recovered?
2. 49 words maximum. Confirm your earliest Boston start date and the largest multinational start-up portfolio you led.
3. 49 words maximum. How have you protected independent approvals while correcting a first-patient forecast?