Global Studies Leader - Gsl

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The Position

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, minimising 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

Who we are

A healthier future drives us to innovate. Together, more than 100’000 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.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.