Record to Report CLA Senior Analyst Actions

Record to Report CLA Senior Analyst Actions

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. The Position At Roche / Genentech Pharma Product Development Global Clinical Operations (PDG), we are determined to transform drug development and realize our Pharma Ambition to deliver 20 transformative medicines addressing diseases with the highest societal burden by 2029. PD’s mission is to improve patients’ lives around the world through unique medicines that have a meaningful impact. Cross functionally we conduct global clinical trials, analyze results, monitor safety, and work with regulatory authorities to provide truly differentiated medicines to patients. The Global Asset Study Manager (GASM) at Roche / Genentech is responsible for the consistent and efficient execution of global operations for a group of studies related to an asset, or within a Disease Area (DA) or Therapeutic Area (TA). This role involves working closely with internal teams and partner operations, as well as cross-functional experts and vendor partners, to ensure smooth operational delivery. The Opportunity : Co-ordinate and deliver the study management aspects of a group of studies within an asset’s portfolio following IHC-GCP and Roche processes in accordance SOPs and guidelines to ensure the clinical study progresses as planned Provide input into the development of essential study level documents (eg study protocol, TMP, Pharmacy manual). Develops a study's recruitment expectations in partnership with APO, Roche countries and the partner CRO and develops and maintains a forecast using the appropriate systems (EFT) Develop and / or maintain or provide input in collaboration with CRO partners, study management essential documents (EG Pharmacy manual, relevant study plans / relevant training materials (EG IMP management)) Drive innovation in clinical operations by thinking of and contributing to the implementation of new approaches in partnership with COE, APO and HBS in order to deliver outcomes that meet and exceed industry best practices. Build and role model effective study partnership behaviors and mindsets with your TA aligned CRO partner to ensure we maximize the expertise of the CRO and our internal colleagues, minimising duplication of work and ensuring cost and resource efficiency for study(ies) in responsibility Develop and oversee key performance indicators (KPIs, quality and operational) for areas of responsibility by using company tracking systems and proactively communicating any risks to timelines and / or quality, or identified quality issues, along with proposed mitigations to your Global Studies Leader Maintain inspection readiness of the relevant components in scope of responsibility Lead 3rd party vendor selection Vendor identification set up, and oversight and close out to ensure delivery to contract (in line with relevant iCOP strategies and study level needs) Produce, arrange translation & distribute patient and site facing support materials Management supply and shipment of IMP Obtain and distribute clinical trial insurance Regularly seek and provide feedback to study team members on their individual performance to support their professional development and contribute to the achievement of a High Performing Organization Who You Are : You have 5-7 years' of relevant operations experience You have an undergraduate degree or equivalent years of experience, preferred focus in life sciences You possess a strong working knowledge of drug development process and respective regulations, including ICH and GCP guidelines You are a self-starter who finds passion in achieving successful outcomes You want to make a difference and find excitement in innovating practices, products and processes You have a growth mindset and are excited about learning through experience You feel comfortable thinking on your feet and thrive in fast-paced, ambiguous and highly collaborative environments Preferred Qualifications : You have prior clinical trial management Roche is an Equal Opportunity Employer.

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