Clinical Trial Manager
vor 1 Tag
Numab Therapeutics AG, with its US subsidiary Numab US LLC, is an expanding, clinical stage Swiss biotech
company based in Horgen, canton of Zürich. The company is focused on the discovery and development of novel,
antibody fragment-based therapeutics. With our breakthrough antibody-discovery and multi-specifics
engineering platform, we engage in proprietary projects as well as collaborative research on behalf of partners
in the pharmaceutical industry.
For our Clinical team, we are looking for a highly motivated and enthusiastic person to join us as:
**Clinical Trial Manager 100%
Key responsibilities will include the planning and implementation of global clinical development programs for
project management and operations, as well as excellent writing and presentation skills, be detailed-oriented
and possess the ability to carry out multiple tasks while maintaining a high level of quality. This role will report
working with highly motivated and passionate people. Applicants must have also demonstrated strong
interpersonal and verbal communication skills.
**Your responsibilities**
- Oversee clinical program execution, ensuring adherence to budgets and timelines, while delivering
exceptional quality.
- Develop and implement project plans in accordance with Numab SOPs and clinical protocols.
- Provide periodic updates on study metrics/key performance indicators (KPI).
- Support outsourcing and internal resource planning for clinical programs inclusive of development of
Requests for Proposal (RFPs); vendor/CRO qualification, selection, and contracting; and determination
of need for contract staff to support clinical trial activities.
- Support preparation of vendor/CRO and site agreements, contracts, and budgets/payment terms.
- Manage vendors/CROs and ensure that contracted scope of work is performed in accordance with
agreements and study plans, all applicable regulations, and with a high level of quality.
- Lead team meetings and ensure coordination between various functional groups working to execute the
clinical trial.
- Direct protocol and site feasibility efforts, and oversee selection, qualification, and contracting of sites,
as well as training of site staff.
- Coordinate site management activities, including monitoring and regulatory document collection.
- Lead day-to-day clinical operations activities including, but not limited to, identification, training, and
mentorship of clinical monitors, and perform co-monitoring/oversight to ensure their compliance with
GCPs and Numab Standard Operating Procedures (SOPs); additionally, CTM will define and implement
standards, goals and expectations for clinical operations staff (in-house, contract, and/or outsourced).
- Review and/or develop informed consent documentation, case report forms, study plans (e.g., data
management plans) ensuring all meet the highest standards and best practices for clinical trials
- Assist and support data cleaning/query process.
- Perform routine risk identification and mitigation.
- Contribute to development of Standard Operating Procedures and associated documentation related to
clinical program management for Numab’s Quality Management System
- Ensure clear clinical program team communication, process documentation, and compliance with Good
Clinical Practice and Numab SOPs.
**Your profile should ideally include**:
- Passion for patients and clinical research to advance available treatment options
- Robust knowledge of ICH GCP and other regulations governing execution of clinical trials
- Prior success leading cross-functional teams and/or mentoring junior staff in clinical operations
- Ability to anticipate and plan for potential issues in trial execution, and to proactively implement risk
mitigation strategies
- Strong verbal and written communication skills
- Ability to think analytically and convey complex ideas to various audiences
- Experience designing and implementing eClinical systems (e.g., electronic data capture [EDC], etc.)
preferred
- Excellent writing and presentation skills; superior organizational and budgeting skills; detail-oriented
- Ability to travel, both domestic and internationally, approximately 20%, as needed
- A positive mental attitude and team orientation
- In-depth knowledge of all aspects of clinical trial execution, inclusive of basic understanding of
supporting functions and their deliverables (e.g., Data Management, Biostatistics and Programming,
Medical Writing)
- Ability to implement corrective actions as needed to maintain project performance, quality, and data
integrity
- Excellent organizational and interpersonal skills, with proven ability to develop positive working
relationships with individuals and teams both internally and externally
- Advanced user of MSOffice Suite (e.g., Word, Excel, Project, PowerPoint, Outlook)
- Able to work independently as well as collaboratively, with a sense of urgency, in a matrixed
environment
**Minimum Qualifications**:
- BS
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