Clinical Operations Manager / Expanded Access Programs– 6952, Basel

Our client is an innovative mid-size Pharmaceutical company with global headquarters in the German speaking part of Switzerland. A well-funded and stable organisation, our client enjoys the backing of a number of leading, globally recognised institutions. They currently market 3 leading products in anti-infectives via a global alliances and extensive partner network. We have a long standing relationship with this company and have placed a number of key people in the organisation in the past, all of whom have given us some great feedback from their time working there.

Purpose Participates in the planning and execution of one or more clinical trials or Expanded Access Programs including preparation of trial documents, management of Trial Master File and investigational sites. Responsible for management and oversight of CROs and third-party vendors. Has a good understanding of ICH-GCP, compliance policies and relevant SOPs. This is primarily an in-house position, but some co-monitoring or oversight activities at sites or vendors may be required. It’s a 6 month maternity leave replacement contract.

Main Responsibilities

Planning, set-up, conduct and closeout of trials (phase 1 to phase 3)

Planning set-up, conduct and closeout of an Expanded Access Program

Accountable for operational leadership and delivery; Cooperates with relevant functions to deliver the trial within timelines, budget and with high quality

Prepares trial budgets, forecasts, timelines, and project plans

Contributes to requests for proposal; Negotiates contracts and budgets for assigned projects

Ensures close CRO surveillance and management of other third-party vendors (central labs, IWRS, clinical supply distributors, etc.)

Provides input to clinical study protocols, investigator’s brochure, informed consent sheet, etc.

Prepares trial related documents (manuals, guidelines, visit reports, newsletters); reviews and contributes to study

Performs UATs for systems implemented on a trial

Plans and leads or participates in project meetings, training workshops and investigators meetings

Supervises training of cross-functional study team members to assure consistency and compliance in conduct and monitoring of clinical trials

Prepares and distributes regular and ad hoc reports, summaries, or analyses as required; Prepares status reports for assigned clinical trials

Conducts co-monitoring and oversight visits

Participates in internal/external audits

Ensures TMF/eTMF is set-up adequately, checked on a regular basis and kept up to date

Ensures inspection readiness

Qualifications and Experience

Relevant working/residency permit or Swiss/EU-Citizenship required.

At least 5 years’ experience in managing clinical trials phase 1 - 3, preferably from CRA level up to global clinical trial manager

Solid understanding of clinical trial systems (EDC, IRT, eTMF, CTMS, etc)

Robust knowledge of ICH-GCP and clinical trial regulations in multiple countries Previous involvement in internal audits and regulatory authority inspections is a plus

Effective communication, organizational, problem solving and time management skills

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