Clinical Trial Manager

Numab Therapeutics AG is an expanding, clinical stage Swiss biotech company based in Wädenswil, 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

Numab products. Importantly, successful candidates will possess significant, relevant experience in clinical

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

to the Director of Clinical Operations. The ideal candidate will thrive in an energetic, fast-paced environment,

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

Numab Therapeutics AG | Einsiedlerstrasse 34 | CH-8820 Wädenswil | Switzerland | www.numab.com

• 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/BA (or equivalent) in one of the life sciences, as well as 5+ years of direct experience in global

clinical trials management and/or clinical operations roles

• Experience in either oncology or dermatology, early phase clinical research, and

biologic/immunotherapy development strongly preferred

• Excellent strategic thinking skills, and successful track record of executing clinical studies on time,

and within allocated budget

Are you looking for an inspiring, entrepreneurial atmosphere and want to be part of a dynamic team where your

contributions are both essential and valued? We are looking for skilled people who are eager to make an

impact. We are offering a permanent position in an innovative environment as well as a competitive

compensation package including a participation in the company.

We are looking forward to receiving your application with reference number NB071 to hr@numab.com.

Numab Therapeutics AG | Einsiedlerstrasse 34 | CH-8820 Wädenswil | Switzerland | www.numab.com