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Site Oversight & Delivery Activities

? Establish and manage site relationships, including but not limited to:

? Act as liaison between the company and investigational sites, building investigator and site staff awareness on client compounds

? Develop and implement a plan, in collaboration with global and local teams, to raise the profile of the company and its global clinical development projects with current and potential investigators

? Independently perform activities associated with the evaluation of investigational sites to build company network

? Proactively work with Medical/Patient/Industry Associations to build company network and to promote company clinical trials

? Develop knowledge of site capabilities and past performance to assess their potential as participating sites in client clinical trials

? Ensure regular communication with local organization to align interactions with KTLs and other relevant local/regional stakeholders

? Oversee site-level study start-up, conduct, and close-out activities outsourced to CRO(s) for global programs across Therapeutic Areas, including but not limited to:

? Support Site Agreement negotiations, including stand-alone and Master Site Agreements

? Identify trends, issues and risks across sites, and work with external vendors and internal Trial Team to resolve/mitigate those

? Collaborate with external vendors and internal Trial Team, to ensure that sites are activated in a timely manner and according to agreed timelines

? Collaborate with external vendors and internal Trial Team, to ensure that sites deliver on expected recruitment targets, including identifying reasons for non-recruitment, and identification of non-performing sites that require actions

? Ensure ICH/GCP/local regulatory requirements are observed

? Provide documented sponsor site oversight at country level for outsourced trials in country under remit as required by regulation

? Utilize site performance and quality data to optimize prioritization of oversight actions

? Drive documented sponsor site oversight at country level for outsourced trials in country under remit as required by regulation

? Utilize advanced analytics to optimize prioritization of oversight activities

Therapeutic Area Expert Assignement

? SME with focus to increase disease knowledge within the team by sharing materials (training/articles/abstracts) and/or arranging training sessions

? Ensure that clinical sites in country(ies) of responsibility are activated within agreed timeframe and company agreed cycle times

? Work closely with respective Clinical Site Leads to support them in issue resolution for site activation

? Collaborate with external vendors to identify process(es) requiring improvement at the country level, build action plans to strengthen/improve those and track impact of actions

? Support OSM model by acting as a local SME

? Identify trends and issues within/across assigned trial(s) which may impact key deliverables (e.g. timelines/quality/costs) and implement action plans to either resolve and/or mitigate those

? Advise the Trial Team on trends/issues and facilitate solutions, working closely with the CTL to ensure Corrective & Preventive Actions are defined and implemented. Raise awareness of such trends/issues with Clinical Site Leads and other internal and external stakeholders as appropriate, including ICSO/CTE Leadership

? Develop, implement and follow up on strategic action plans to drive improvements in site activation and/or enrolment, in collaboration with the CTL, CRO(s) and working closely with the respective Clinical Site Leads

? Participate in Investigator/Study Coordinator Meetings and promote information sharing with the Clinical Site Leads as needed

? Manage company/department improvement initiatives as leadership role, with strategic impact and delivery accountability.

? Take the lead and be the business process owner of the expert area, responsible for:

- to define process goals

- to design and document business requirements

- to ensure harmonization and standardization of the process

- to act as interface between functional managers and process team

- to ensure implementation of optimization measures

- for process monitoring/controlling, analysis and continuous improvement

? Has good organizational understanding, relevant product, Clinical research landscape knowledge and ability to leverage this expertise to achieve objectives

? Interprets and anticipates internal and external business challenges and recommends best practices to drive process improvements

? Is recognized as an expert within ICSO and beyond; with peers within the same technical area in the business; as well as other key business functions

? Serves as best practice resource within ICSO; may also act as a technical expert on cross-functional teams or projects

? Handles sensitive issues and guides, influences and convinces colleagues in other teams/functions as well as external partners

? Impacts through successful execution of projects within ICSO/CTE

? Oversee external providers as applicable

• CTE Functions

• Early & Late Stage Dev Operations

• Development Unit Clinical Leads

• (Global) Medical Affairs

• (Global) Regulatory Affairs

• SBDO China & Japan

• R&D Quality

• Other functions as needed

• Clinical Research trial sites (Institutions/Investigators)

• Ethics Committees/ Regulatory Authorities (e.g., ECs/IRBs); if applicable

• Hospital administration

• Pharma Industry working groups

• Vendors (CRO)

• Patient Associations

Requires graduate background (Medical or Life Sciences degree) in a clinical research related discipline or equivalent

? Detailed understanding of all aspects of clinical protocol design and implementation, clinical site monitoring as well as overall global drug development

? Expert knowledge of clinical development (principles and concepts as well as regulatory environment e.g. ICH GCP and applicable regional/local regulations)

? Oncology and/or Neurology and/or Immunology TA experience desired

? Substantial (8+ years) experience in clinical operations in a CRO, pharma or biotech company including site management/oversight, and site-level clinical study conduct

? Extensive (10+ years) experience in clinical operations in a CRO, pharma or biotech company including site management/oversight, and site-level clinical study conduct

Extensive (15+ years) experience in clinical operations in a CRO, pharma or biotech company including site management/oversight, and site-level clinical study conduct

? Strong communication skills (verbal, written and listening) in both native language and English

? Aptitude to interpret and to integrate site performance data in prioritization of oversight activities

? Ensuring compliance with applicable T&E Policy requirements

? Role requires domestic and international travel up to 50% of time

? Ability to work independently on assigned tasks or projects of increasing complexity

? Capability to perform self-training incl. on therapeutic area, and synthesize the key take-away points for studies under remit

? Normally receives no instruction on routine work and only general instruction on new assignments

? Sound negotiation skills and adapting to a variety of parties

? Record of vendor interactions

? Sound critical thinking skills and ability to understand complex patient histories, medical terminology and specific therapeutic area treatment landscapes

? Detail-oriented, organized and committed to quality and consistency

? Results driven and capable of managing competing high-priority assignments

? Proven track record of achieving deliverables within specified timelines

? Ability to work in a dynamic environment with a high degree of flexibility

? Ability to communicate effectively with Key Opinion Leaders, site staff, and internal team members Experience and proven proficiency in CTMS and eTMF systems preferred

? Ability to work independently on assigned tasks or projects of increasing complexity and/or sensitivity

? Capability to perform self-training and - if assigned as an SME (TA Expert, Country Start-Up Specialist, Trial Clinical Site Lead) - able to lead, coach and train other team members

? Clearly conveys and receives information and ideas through a variety of media to individuals or groups, both internally and externally in a manner that engages the listener, helps them understand and retain the message, and invites response and feedback.

? Uses appropriate interpersonal styles and techniques to reduce tension and/or conflict between two or more people; able to size up situations quickly; able to identify common interests; facilitates resolution.

? Acts without being asked or required to; achieves goals beyond job requirements; being proactive; taking prompt action to accomplish objectives

? Effectively exploring alternatives and positions to reach agreements and solutions that gain the support and acceptance of all parties.

? Record of successful vendor interactions

? Record of risk taking

? Ability to build constructive working relationships with KOLs and clinical site personnel, other departments, and stakeholders to meet mutual g