Global Study Start-up Manager

Vor 4 Tagen


Home Office, Schweiz Hengrui Europe Therapeutics AG Vollzeit

The Study Start-up (SSU) Manager is responsible for execution and
delivery of end-to-end start-up activities from site feasibility through site
activation, serving as the primary point of contact for the site and the study
team. The Manager will coordinate site feasibility assessments, site
qualification, essential document collection and review, and all related site start-up
activities. Incumbent will drive efficiency and adherence to FDA
regulations, ICH-GCP, and functional procedures to ensure a smooth, high
quality start-up process. The SSU Manager will be responsible for
co-development and implementation of start-up-related templates, processes, and
SOPs.

Tasks
- Serve as the key point of contact for assigned trials related to SSU.
- Provide, receive, and analyze feasibility questionnaires from sites; share feedback

and recommendations on-site qualifications for to study team. qualification to study team.
- Conduct full review of essential document package and partner with site to ensure all documents are completed correctly according to Hengrui USA processes and complete sign-off.
- Conduct full review of essential document package and partners with site to ensure all documents are completed correctly according to Hengrui USA processes and complete sign-off.
- Track status of all essential document packages for assigned studies.
- Partner with Clinical Contracts Manager(s) on the execution of CDA, CTA and budget
- Represent study and site start-up activities on cross-functional study teams.
- Routinely present status, risks, issues, targets, and resolution of all start-up

activities during study team meetings.

training to internal and/or external study teams on expectations/standards
of site essential documentation and all other start-up activities.
- Partner with Clinical Contracts Manager(s) on the execution of CDA, CTA and budget

**Requirements**:
**Experience / Education**:

- Bachelor’s degree with 6+ years of clinical research experience in Phase I-IV

studies.
- At least 3 years of experience in SSU leading start-up projects.
- Knowledge and experience with clinical SSU requirements.
- Experience working directly in a pharmaceutical company or Contract Research
- Experience in the clinical drug development process and study management,

specifically SSU activities, such as site feasibility, essential document collection, review, and approval, and IRB submissions.

**Knowledge / Skills / Abilities**:

- Highly motivated with attention to detail and ability to manage multiple tasks in

a fast-paced environment.
- Strong knowledge of MS office software and clinical systems such as CTMS and

eTMF.
- Ability to develop pragmatic and creative solutions to study start-up challenges

and issues.
- Strong collaboration / team results oriented to engage and inspire others to

achieve study start-up goals and timelines.
- Communicates professionally, clearly, concisely, and consistently both verbally and in writing to internal and external customers.
- Experience working directly in a pharmaceutical company or Contract Research


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