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. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
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 PDG’s 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 PDG’s 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, 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
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
Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Shanghai. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process.
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.