We are seeking a highly organized Clinical Trial Manager to join our Clinical Research and Development (ClinResDev) team. In this pivotal role, you will manage the operational planning, execution, and oversight of company-sponsored clinical trials from start-up through closeout. You will ensure alignment with timelines, budget, and regulatory standards (GCP, SOPs), while contributing to trial design and document development. This role involves close collaboration with cross-functional teams, CROs, and clinical sites, as well as active participation in vendor selection, risk mitigation, and issue resolution. Ideal candidates will bring a strong background in immunology, hematology, or oncology, and have demonstrated experience managing complex clinical trials in a highly regulated environment.

Within this role, this Clinical Trial Manager will:

• Coordinate and manage the set-up of internally approved company sponsored clinical trials including planning, preparation, conduct, supervision and termination/abortion.
• Operationally manages the assigned trial(s) in accordance with budget, timelines and quality as well as regulatory compliance of projects (GCP guidelines, regulations and applicable SOPs).
• Provide trial-related operational input to the CRD Project Development Team with respect to the defined deliverables.
• Sets-up, monitors and adapts the trial-specific cost plan.
• Assign and monitor trial-specific trainings of the Trial Operations Team members, including the documented handover of tasks to new team members.
• Coordinate the writing and revision of trial-specific documents, e.g. Protocol (and amendments), Patient Information / Informed Consent, CRF, Investigator’s Brochure, as well as plans and manuals as defined in the Trial Management Plan.
• Ensure the handover of trial documents required for regulatory submissions to internal Regulatory Affairs or to assigned CRO, or conducts regulatory submissions, as defined in the trial-specific RACI and according to outsourcing strategy.
• Conduct and monitor submission to ethics committees or ensure handover of trial documents to assigned CRO, as applicable, as defined in the trial-specific RACI, in accordance to outsourcing strategy and contracts with clinical trial sites.
• After collaboration with the Project Lead, Subject Matter Experts (such as Clinical Trial Supplies Manager, Clinical Data Manager, Biostatistician etc.) and the Manager Clinical Operations, proposes the outsourcing strategy to the decision committee.
• Implement contracts with vendors and conducts oversight with respect to quality, time and budget deliverables
• Monitor the workload and the performance of the internal Trial Operations Team.
• Develop effective relationships with clinical trial sites and vendors.
• Plan and participate in trial-specific meetings e.g. Project Meetings, Trial Execution Team Meetings, Expert Meetings, Investigator Meetings, Vendor Meetings.
• Ensure effective handling of trial-related issues, their escalation if required, their reporting as required and their closure, according to processes.
• Implement trial-specific risk handling in terms of identification, mitigation and review to ensure high quality and timely delivery of set goals.
• Implement together with the Operational Trial Team members and other relevant SMEs issue resolution and lessons learned.
• Perform co-monitoring visits if necessary.
• Contribute to the creation and revision of GXP-related process descriptions, such as Policies, SOPs, templates, workflows for medicinal products and/or medical devices.

Requirements:

• Bachelors, Masters, or PhD in clinical research related discipline (chemistry, biology, pharmacy, medicine or similar)
• 5 years’ experience in clinical research area, including approx. 2 years managing clinical trials
• Experience working in immunology, hematology, oncology, and/or cellular therapy; or equivalent combination of education and experience.

Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail. Must be able to travel routinely by car and plane.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature controlled, handicap-accessible facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in an office environment. This job requires the person to be mobile to visit clinical trial sites. Due to the travel requirements, this position may be exposed to natural elements of nature. Used research/clinical equipment may be handled in this job and strict SOPs must be followed and PPE may be required to be worn per Miltenyi or hospital policies.
Miltenyi Biotec, Inc. is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity. Miltenyi Biotec, Inc. participates in E-Verify.
Are you ready to partake in the personalized medicine revolution? Miltenyi Biomedicine is a biopharmaceutical company developing personalized chimeric antigen receptor (CAR) T-cell therapies. We are developing innovative treatments for serious life-threatening diseases and are reshaping their accessibility to patients worldwide with the goal of improving and prolonging patients’ lives. We are currently focusing on difficult-to-treat hematological cancers using CAR-T and other technologies, while also exploring treatments for other diseases. Our lead candidate, currently in pivotal clinical trials globally, is a tandem CAR T-cell product.

• Coordinate and manage the set-up of internally approved company sponsored clinical trials including planning, preparation, conduct, supervision and termination/abortion.
• Operationally manages the assigned trial(s) in accordance with budget, timelines and quality as well as regulatory compliance of projects (GCP guidelines, regulations and applicable SOPs).
• Provide trial-related operational input to the CRD Project Development Team with respect to the defined deliverables.
• Sets-up, monitors and adapts the trial-specific cost plan.
• Assign and monitor trial-specific trainings of the Trial Operations Team members, including the documented handover of tasks to new team members.
• Coordinate the writing and revision of trial-specific documents, e.g. Protocol (and amendments), Patient Information / Informed Consent, CRF, Investigator’s Brochure, as well as plans and manuals as defined in the Trial Management Plan.
• Ensure the handover of trial documents required for regulatory submissions to internal Regulatory Affairs or to assigned CRO, or conducts regulatory submissions, as defined in the trial-specific RACI and according to outsourcing strategy.
• Conduct and monitor submission to ethics committees or ensure handover of trial documents to assigned CRO, as applicable, as defined in the trial-specific RACI, in accordance to outsourcing strategy and contracts with clinical trial sites.
• After collaboration with the Project Lead, Subject Matter Experts (such as Clinical Trial Supplies Manager, Clinical Data Manager, Biostatistician etc.) and the Manager Clinical Operations, proposes the outsourcing strategy to the decision committee.
• Implement contracts with vendors and conducts oversight with respect to quality, time and budget deliverables
• Monitor the workload and the performance of the internal Trial Operations Team.
• Develop effective relationships with clinical trial sites and vendors.
• Plan and participate in trial-specific meetings e.g. Project Meetings, Trial Execution Team Meetings, Expert Meetings, Investigator Meetings, Vendor Meetings.
• Ensure effective handling of trial-related issues, their escalation if required, their reporting as required and their closure, according to processes.
• Implement trial-specific risk handling in terms of identification, mitigation and review to ensure high quality and timely delivery of set goals.
• Implement together with the Operational Trial Team members and other relevant SMEs issue resolution and lessons learned.
• Perform co-monitoring visits if necessary.
• Contribute to the creation and revision of GXP-related process descriptions, such as Policies, SOPs, templates, workflows for medicinal products and/or medical devices