Senior Clinical Trial Manager *PC 864

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.

Your Tasks:

The Senior Clinical Trial Manager drives the clinical trial execution activities for assigned clinical trials, and ensures trial deliverables are met according to timelines, budget, operational procedures, quality standards, GCP, SOPs and business guidelines.

Essential Duties and Responsibilities:

• Provide input to the clinical development plan and operational aspects of the clinical trial protocol (e.g., develops and/or reviews operational plans for trials).
• Lead cross-functional trial execution team to ensure delivery of complex clinical trials and manages protocol execution.
• Identify and/or anticipate operational risks and mitigation plans within assigned clinical trials and escalates issues and recommends contingency plans to Director of Clinical Operations, as necessary.
• Establish study milestones and ensure accurate tracking and reporting of study metrics, timelines, update of trial information in all trial databases and tracking systems.
• Provide monitoring oversight including authoring of oversight plan, reviewing monitoring visit reports and perform periodic oversight visits to sites and/or vendors to assess progress and compliance.
• Manage clinical trial budgets, providing ongoing financial reporting and projections to the finance group and facilitate the development of clinical trial agreements, insurance and other relevant documents in conjunction with legal.
• Ensure the Trial Master File (TMF) is maintained throughout the trial and performs inspection readiness checks throughout the lifecycle of the trial.
• Serve as functional area reviewer of global clinical / regulatory submissions.
• Present study status reports of operational execution activities to senior management.
• Provide study specific mentor and training for in-house Clinical Research Associate(s) and/or Clinical Trial Assistant(s).
• Participate in operational process improvement initiatives (including training, SOP review and development of work instructions/tools/templates).

Requirements:

• Bachelor's degree in Life Sciences or similar; A minimum of 4 years of direct clinical study management experience working as a clinical trial manager or clinical project manager is required; or equivalent combination of education and experience.
• 8 years of clinical research experience at a Biotech/Pharmaceutical or CRO company.
• Experience managing early phase drug development studies is preferred.
• Oncology therapeutic experience is preferred.
• Global clinical trial experience and the ability to support more than one clinical trial is required.
• Good working knowledge of the international conference on harmonization (ICH) and good clinical practice (GCP) guidelines and other applicable regulatory guidelines required.
• Excellent communication skills, ability to build strong relationships with peers and cross functional team members and CRO/Vendor partners, experience mentoring clinical study staff and presenting to senior management is required.
• Excellent computer skills (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook; Electronic Data Capture Systems).

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 Biomedicine is expanding and evolving. Our culture is one that empowers you to embrace new challenges and influence change. Join a fresh and collaborative working environment that encourages contribution, innovation, and growth.

We empower great science. For more than 35 years, Miltenyi has provided innovative tools, instruments, and solutions that advance biomedical research and cellular therapy. We are 2,000 scientists, engineers, physicians, support specialists, marketers, and more - all dedicated to improving scientific understanding and impacting human lives. At our headquarters campus and offices worldwide, fresh ideas become unique products.

Miltenyi Biomedicine, Inc., is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

Miltenyi Biotec, Inc. participates in E-Verify.