Global Studies Leader

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The Position

The Global Studies Leader (GSL) in PDG at Roche/Genentech is accountable for the delivery of the operational components of one or more clinical studies from Phase Ib-IV in line with the Asset and Therapeutic Area (TA)/Disease Area (DA) strategy timelines budget and quality expectations including timely and accurate data entry in our systems and in close partnership with the TA aligned CRO partner. They are accountable for leading one or more cross functional Study Management Teams that oversee the delivery of a clinical protocol from protocol synopsis through study close. They are expected to hold strong functional and cross functional leadership and influencing skills and work in close collaboration with external partners.

Stakeholder Expectations

Build strengthen and influence a broad cross-functional study level network through collaboration advice seeking and informed decision-making. The stakeholders include but are not limited to:

PDG:

In line with the asset under investigation in your clinical study partner closely with the appropriate Global Operations Asset Leader (GOAL) to seek clear understanding advice and approval (where required)

leverage PDGs Analytics and Portfolio Optimization (APO) and Clinical Operations Excellence (COE) expertise to support acceleration enhance efficiency ensure quality manage budget and ensure a patient- and investigator/site-centric approach including health equity research commitments.

Partner effectively with Country Therapeutic Area Leaders and Clinical Research Engagement Leads to ensure early and ongoing country perspective in study strategy development and decision making study design and execution. Supporting local Therapeutic Area Expert (TAE) patient advocacy and investigator/site relationships when appropriate.

Partner effectively with PDGs Human Biosamples team to support adherence to bioethics quality and compliance needs of human biosamples in sample collection storage and destruction.

PD and Roche Enterprise: Collaborate effectively with the cross functional members of the Study Management Team guiding and influencing decision making as appropriate and engaging with the Global patient partner Global Development or Lifecycle Team as appropriate.

Through partnering with the Global Studies Asset Manager (GSAM) Global Operations Asset Leader (GOAL) and the CSP office support the understanding of any study-level vendor performance issues escalating as appropriate for both help and transparency.

External Stakeholders: Proactively identify develop and maintain collaborative relationships with key external partners

CRO partner: Collaborates and builds strong trusting relationships with the TA aligned CRO partner team to deliver quality study data on time and in budget.

As the Study Management Team Lead your key responsibilities include:

Lead and coordinate a cross-functional study team of experts in compliance with ICH-GCP and Roche processes in accordance SOPs and guidelines to ensure the clinical study progresses as planned through driving the achievement of milestones according to timelines budget and quality standards

Provide input into and hold accountability for the development of essential study level documents (i.e. Clinical Study Protocol Clinical Study Report) in accordance with relevant SOPs

Develop and maintain in collaboration with CRO partners quality risk strategy relevant study plans and data to drive clinical study execution and allow adequate oversight

Accountable and responsible to ensure data entry timeliness and accuracy in our systems regardless of who is accountable or responsible for entry of the data

Lead/facilitate communication across all functions and provide guidance and support to the core and extended study team members as needed

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 minimizing duplication of work and ensuring cost and resource efficiency for study(ies) in responsibility

Ensure all external service providers (ie CROs IXRS ePRO etc.) that are engaged at the study level are delivering to their contractual obligations within the agreed timelines and budget and that oversight is documented and issues escalated as appropriate.

Oversee study level performance against agreed upon plans milestones and key performance indicators (KPIs quality and operational) 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 Operations Asset Leader and your People leader

Oversee Trial Master File (TMF) completion in accordance with relevant SOPs ensuring QC activities are performed on an ongoing basis to maintain TMF completeness at all times

Ensure timely compliance with company-wide governance controls (e.g. Delegation of Authority Sunshine Act)

Develop and oversee the study budget throughout the study lifecycle including budget re-forecasting identification of any financial risks and enactment of mitigation plans. Including proactive communication of financial risk and mitigation plans to the GOAL

Maintain study inspection readiness at all times according to ICH-GCP and relevant SOPs policies/guidelines and support for asset filings; the GSL is the primary Study point-of-contact in the event of a study audit or inspection

Provide study team members and their line managers with regular feedback on their individual performance to support their professional development and the achievement of a High Performing Organization

Work on non-asset project work such as the Subject Matter Experts (SME) representative in change initiatives that drive process improvements and/or lead improvement projects as discussed and agreed upon with their manager

Qualifications:

University degree (or equivalent) preferably in medical or biological sciences or discipline associated with clinical research

Minimum of 7 years of relevant clinical experience in R&D in the pharmaceutical industry including 2 years project management experience or equivalent combination of education training and experience

Extensive knowledge of clinical research regulatory requirements and demonstrated abilities in clinical study management processes and clinical/drug development

Demonstrated solid project management skills and knowledge of relevant tools

Strong demonstrated abilities/skills in team leadership

Strong abilities in establishing and maintaining effective working relationships with internal and external co-workers and stakeholders along with strong conflict management skills

Excellent communication and interpersonal skills

Strong strategic and critical thinking abilities

Strong organizational and problem-solving skills

Ability to manage competing priorities

Some international and/or domestic travel may be required

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.