Senior Manager, Clinical Trial Supplies, Oncology
3 weeks ago
DescriptionHere at Ascendis we pride ourselves in exceptional science, visionary leadership, skilled and passionate colleagues.We are a dynamic, fast-growing biopharma company with offices in Denmark, Germany, and the United States. Today, we’re advancing programs in Endocrinology Rare Disease, and Oncology. Guided by our core values of patients, science, and passion, we use our TransCon drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs. Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We are a dynamic workplace for employees to grow and develop their skills. The Senior Manager, Clinical Trial Supplies (CTS), Oncology will work as an integral member of the Ascendis Global CTS Oncology team, managing all aspects of Investigational Medicinal Products (IMP), Clinical Trial Supplies, Comparators and ancillary products used in Ascendis Oncology Clinical Trials. The successful candidate will support the Ascendis CTS Oncology team with sponsored and/or collaborative clinical and non-clinical studies. The core responsibilities include IMP and comparator forecasting and inventory management, IRT Design and maintenance, CTS team study operations, ownership of distribution tracking for clinical studies, managing in documentation review and archiving to coordinate and track all CTS packaging, labeling, distribution, inventory, returns and destruction of IMP/CTS. The position closely interacts with Clinical Operations, Quality Assurance, and Regulatory groups, and with external vendors as assigned. ESSENTIAL DUTIES: Responsible for complex Oncology IMP/CTS forecasting, inventory management and documentation for complex multi-cohort/product types in Ascendis global oncology clinical trials. Must be adept in Microsoft Excel. Manage bulk depot and individual site shipments, track and follow through receipt and release to ensure supplies available to sites at all times with minimal to no waste or missed patient doses.Coordinate and responsible for pack/label and distribution activities, review, approve and file related documents.Represent CTS oncology with IRT URS development, UAT execution, ongoing monitoring and maintaining of IRT reports to provide weekly drug projections.Coordinate CMO planning and drive through approvals for labeling (in multiple languages), packaging, inventory, distribution, and reconciliation/returns/final destruction of IMP/CTS for global clinical studies. Manage product complaint processing by gathering information, processing and filing of documentation through disposition.Consistently verifies status of clinical trials enrollments and ensures depot and sites inventories are monitored and supplied with IMP/CTS required to ensure continuity of supplies, no missed doses.Manage review, drive to approval labeling variable data fields, Packaging Specifications, Product shipping and storage specifications etc. Provide broader Clinical Supplies Team with document management & administrative support as required.Maintain compliance with all applicable Ascendis CTS SOPs re: CTS handling and management and CTS import / export regulations. SOP and WI writing, as assigned. Gather data and maintain applicable metrics to monitor performance relative to clinical trial inventory, and planning.Attend meetings and responsible for generating, maintaining, and archiving of team meeting minutes and presented materials, as required.Provide general CTS support to other projects and products, as assigned.RequirementsBachelor’s degree in applicable discipline and minimum of 7 years professional experience in CTS pharmaceutical or equivalent biotech industry role. Experience in supporting management of complex distribution IMP/CTS supply chains for open label, blinded, double-blinded, placebo-controlled clinical trials in global geographies.Strong understanding and knowledge of CFR and ICH guidelines, regulations and guidelines governing conduct of clinical studies a must.Demonstrated abilities and knowledge international regulations governing transport and distribution, import/export of CTS materials.Minimal travel on company business may be required.Special skills/knowledge:Excellent organizational, written, and verbal communication skills.Adaptability, agility, flexibility, independence, and resourcefulness to multi-task as needed to thrive in a dynamic small company environment.Strong interpersonal skills and ability to function in a dynamic cross-functional team environment.Strong computer software proficiency in spreadsheets, presentations, and word processing software. Advanced Excel skills are a must. Accuracy, compliance, and attention to detail is a must.GMP manufacture experience of drug products for clinical use.Salary range: $165-175K/yearA note to recruiters:We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged.BenefitsMedical insuranceVision insuranceDental insurance401(k)Paid maternity leavePaid paternity leaveCommuter benefitsDisability insuranceJob SummaryID: E0732774BCDepartment: Oncology, Clinical Operations, OncologyType: full time
-
Senior Clinical Trial Manager
1 week ago
Princeton, United States Genmab Full timeAt Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in...
-
Clinical Trial Associate
6 days ago
Princeton, United States UroGen Full time**Job Summary** **Responsibilities**: - Assist in study start up activities including collection and tracking of essential documentation needed for site initiation, maintenance and close out. - Conduct ongoing maintenance of eTMF and quality checks through collaboration with relevant personnel both site level & study level. - Coordinates independently and...
-
VP, Late Clinical Development Oncology
1 week ago
Princeton, United States Bristol Myers Squibb Full timeWorking with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...
-
VP, Late Clinical Development Oncology
1 week ago
Princeton, New Jersey, United States Bristol Myers Squibb Full timeWorking with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...
-
VP, Late Clinical Development Oncology
7 days ago
Princeton, United States Bristol Myers Squibb Full timeWorking with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...
-
Senior Clinical Drug Supply Associate
1 month ago
Princeton, United States Genmab Full timeThe Role & DepartmentGenmab is searching for an enthusiastic Senior Clinical Drug Supply Associate to be part of Global Clinical Drug Supply Operations in Copenhagen or Princeton within commute distance from our office locations to work according to your hybrid work arrangement.Having an impressive pipeline and many ongoing clinical trials, you will have a...
-
Clinical Trials Research Manager
2 weeks ago
Princeton, United States Diverse Lynx Full timeMust Have Master's Minimum five (5) years of clinical trials research involving human subjects. Minimum five (5) years of supervisory responsibility. Minimum five (5) years of Ambulatory Nursing. nice-to-have skills Nurse Practitioner or Clinical Nurse Specialist. Certification in Human Subjects Protection (post hire). Certification in Biohazard Materials...
-
Sr. Consultant, Clinical Trials
5 days ago
Princeton, United States Endeavor Consulting Group, LLC Full timeEndeavor Consulting Group, a leading consulting firm specializing in the pharmaceutical industry, is seeking a highly skilled and experienced Sr. Consultant, Clinical Trials. As a key member of our team, you will play a critical role in assisting our clients with the design, implementation, and improvement of clinical trials. This is an exciting opportunity...
-
Senior Clinical Trial Manager
1 month ago
Princeton, United States TK-CHAIN LLC Full timeJob DescriptionJob DescriptionManage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulationsServe as primary Sponsor contact for operational project-specific issues and study deliverablesMaintain in depth knowledge of protocol, therapeutic...
-
Senior Clinical Trial Manager
1 month ago
Princeton, United States TK-CHAIN LLC Full timeJob DescriptionJob DescriptionManage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulationsServe as primary Sponsor contact for operational project-specific issues and study deliverablesMaintain in depth knowledge of protocol, therapeutic...
-
Senior Clinical Trial Manager
1 month ago
Princeton, United States TK-CHAIN LLC Full timeJob DescriptionJob DescriptionManage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulations Serve as primary Sponsor contact for operational project-specific issues and study deliverables Maintain in depth knowledge of protocol,...
-
Senior Clinical Trial Manager
1 month ago
Princeton, United States TK-CHAIN LLC Full timeManage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulations Serve as primary Sponsor contact for operational project-specific issues and study deliverables Maintain in depth knowledge of protocol, therapeutic area, and...
-
Senior Clinical Trial Manager
1 month ago
Princeton, United States TK-CHAIN LLC Full timeJob DescriptionJob DescriptionManage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulations Serve as primary Sponsor contact for operational project-specific issues and study deliverables Maintain in depth knowledge of protocol,...
-
Sr. Consultant, Clinical Trials
1 week ago
Princeton, United States Endeavor Consulting Group Full timeJob DescriptionJob DescriptionEndeavor Consulting Group, a leading consulting firm specializing in the pharmaceutical industry, is seeking a highly skilled and experienced Sr. Consultant, Clinical Trials. As a key member of our team, you will play a critical role in assisting our clients with the design, implementation, and improvement of clinical trials....
-
Sr. Consultant, Clinical Trials
2 days ago
Princeton, United States Endeavor Consulting Group Full timeJob DescriptionJob DescriptionEndeavor Consulting Group, a leading consulting firm specializing in the pharmaceutical industry, is seeking a highly skilled and experienced Sr. Consultant, Clinical Trials. As a key member of our team, you will play a critical role in assisting our clients with the design, implementation, and improvement of clinical trials....
-
Sr Clinical Trial Physician
1 week ago
Princeton, United States Bristol Myers Squibb Full timeWorking with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...
-
Sr Clinical Trial Physician
1 week ago
Princeton, United States BioSpace, Inc. Full timeJob Details Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that...
-
Sr Clinical Trial Physician
1 week ago
Princeton, New Jersey, United States Bristol Myers Squibb Full timeWorking with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...
-
Sr Clinical Trial Physician
1 week ago
Princeton, New Jersey, United States Bristol Myers Squibb Company Full timeWorking with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...
-
Sr Clinical Trial Physician
7 days ago
Princeton, United States Bristol Myers Squibb Company Full timeWorking with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...