Clinical Project Manager (M/F)

Job description

Nestlé Skin Health is a global leader in improving the quality of life by delivering innovative medical solutions for the health of skin, hair and nails throughout people's lives. Nestle Skin Health aims to meet the needs of healthcare professionals and consumers through constant innovation in technology and products to protect and improve the health of the skin and treat skin diseases.

Nestlé Skin Health is a subsidiary of Nestlé.

For our Global SIG Rx organisation, we are currently looking for:

Clinical Project Manager (M/F)

Based in the Lausanne region of Switzerland, in an innovative and dynamic environment, you will be attached to the Senior Clinical Project Manager:

The Clinical Project Manager (CPM) manages overall clinical operations activities for assigned global clinical trials within Clinical Operations department in coordination with CRO including timelines, budgets, resources, investigational sites, vendors and key project deliverables in compliance with SOPs, Regulatory requirements and ICH/GCP guidelines and in alignment with Strategic & Innovation Group (SIG) strategies and goals. The CPM may serve as project team member for a small programs and coordinate several small clinical study activities with other functions (e.g. RA, CMC) including long-term, next stage planning.

Activities and responsibilities :

· Write the Clinical Trial Outline (CTO) and Clinical Protocol.
· Coordinates all study activities internally and with external vendors.
· Manages selection of study vendors for assigned studies.
· Manages vendor(s) throughout the life of assigned clinical trial(s).
· Selects investigational sites with input from Clinical Development and vendors.
· Responsible for the development of appropriate operating and quality plans (i.e. Clinical Operations Plans, Monitoring Plan).
· Oversees investigative sites' adherence to pertinent regulations through review of monitoring reports, QA-GCP audit reports and communications with investigators, study site personnel & CRAs.
· Leads ongoing review of data to ensure quality and consistency.
· Plans and conducts investigator meetings and ad boards, etc.
· Oversees submission of trial-related and essential documents to the Trial Master File.
· Supports development of Clinical Study Reports (CSR).
· Identifies and provides solutions to clinical trial issues or risks.
· Provides or facilitate training to clinical study teams on protocol specific topics.
· Participates as appropriate in internal and external audits.
· Manages communication of study status and guidance to internal stakeholders.
· Managing the multidisciplinary Clinical Trial Team to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practices.
· Write the Clinical Protocol in accordance with the Clinical Trial Outline.
· Issue the Early and the Final Requests for the clinical supplies.
· Provide input and contribute to the other study related documents.
· Establish budget and timelines for the study.
· Provide input for Feasibility Questionnaire, if any, and provide input for the final selection of the Investigators in relation with his/her Manager.
· Review clinical regulatory documentation for the study submission including but not limited to CTA modules, IB, IMPD, EC, safety reports, labels.
· Provide input for Statistical Analysis Plan (SAP), Data Management Plan (DMP) and safety reports.
· Support coordination and/or organisation trainings and meetings related to the planning and conduct of the Clinical Trial.
· Participate to regular meetings with the Clinical Study Team.
· Track Clinical Trial activities and milestones and provide regular progress reports to SCPM.
· Support preparation of an audit plan with QA and coordinate the completion of adequate responses to audit reports and implement appropriate action plan.
· Support completion and adequate responses to audit reports and support implementation appropriate action plan.
· Participate to the on-going medical/ scientific review of the Clinical Trial data.
· Prepare the data analysis and interpretation including the development of first interpretable results (Top Line Results).
· Provide input in the CSR writing and contribute to the filing modules for the Clinical Study Report.
· Participate to the lesson learn meeting.
· Give input for the Clinical Trial registry (clinical.trial.gov).
· Participate in the selection of CRO
· Review the CRO contract including scope of services.
· Supervise adherence to scope of work within timelines and budget.
· Review, comment and discuss the complete contract (including details on delegated Services) to make it reflect all the study requirements.
· Participate in the selection of qualified investigators.
· Make a risk assessment of the study and update it on a regular basis.
· Track all aspects of the Clinical Trial and make regular progress reports.
· Is involved in, the key messages, writing, document compliance and review of CTD modules and/or other regulatory documents (Briefing Packages, Investigator's brochures, IND/IMPD, CTD, labeling documents, answering questions from HA during the review process, etc..).
· Report progress on deliverables to the Project Team and identify variances and present solutions/alternatives.

Expected qualifications :

· University degree, preferably in a biologic/scientific discipline.
· Minimum of 5 years progressive experience in clinical operations including 3 years of clinical project management or equivalent with Pharma/Biotech and/or CRO.
· Systemic route of administration (large and small molecule) clinical trials experience required; paediatric, drug/device combination and biologics experience preferred.
· Good understanding of country level regulations, ICH and GCP guidelines, cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, and regulatory affairs.
· Ability to travel as required, 30%

Location: Lausanne Region, Switzerland.

Date: As of Q2 2018