- 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.
- Bachelor'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.
- 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/year
- Medical insurance
- Vision insurance
- Dental insurance
- 401(k)
- Paid maternity leave
- Paid paternity leave
- Commuter benefits
- Disability insurance
-
Senior Manager, Clinical Trial Supplies, Oncology
Found in: beBee S2 US - 3 weeks ago
Ascendis Pharma Palo Alto, United States Paid WorkHere 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 D ...
-
Nurse Coordinator
Found in: Zoho Direct Apply - 5 days ago
MFS Talent Redwood City, United StatesJob DetailsShift: Days - 8 hrs, Monday to Friday, 40hrs / week · Location: Hybrid, Redwood City, CA · Duties and ResponsibilitiesAssessing the physical and emotional needs of oncology patients. · Developing and implementing individualized care plans. · Administering chemotherapy ...
-
Administrative Associate 3
Found in: Jobget US C2 - 3 days ago
Stanford University Stanford, CA, United StatesStanford University is seeking an Administrative Associate 3 to provide administrative support working under general supervision in the Department of Radiation Oncology, Division of Radiation and Cancer Biology. The AA will report directly to the Division Manager in the Departmen ...
-
Pharmacy Technician
Found in: Jobget US C2 - 3 days ago
Sutter Health Palo Alto, CA, United States Part timeSutter Health is seeking a Pharmacy Technician for a job in Palo Alto, California. · Job Description & Requirements · Specialty: Pharmacy Technician · Discipline: Allied Health Professional · Start Date: ASAP · Duration: Ongoing · Employment Type: Staff · We are so glad you are i ...
-
assistant clinical research coordinator
Found in: MyJobHelper US C2 - 2 days ago
Stanford University Stanford, CA , USA, United StatesThe Division of Radiation & Cancer Biology in the Department of Radiation Oncology is seeking an Assistant Clinical Research Coordinator to perform research support duties related to the processing of clinical samples, clinical data, as well as assist with coordination of ongoing ...
-
assistant clinical research coordinator
Found in: MyJobHelper US C2 - 2 days ago
Stanford University Stanford, CA , USA, United StatesThe Division of Medical Physics in the Department of Radiation Oncology is seeking Assistant Clinical Research Coordinators (ACRCs) to provide administrative and research support for faculty and the division. ACRCs will assist in the collection and analysis of clinical data and/o ...
-
Pharmacy Technician
Found in: Jobget US C2 - 3 days ago
Sutter Health Palo Alto, CA, United States Part timeSutter Health is seeking a Pharmacy Technician for a job in Palo Alto, California. · Job Description & Requirements · Specialty: Pharmacy Technician · Discipline: Allied Health Professional · Start Date: ASAP · Duration: Ongoing · Employment Type: Staff · We are so glad you are i ...
-
Associate Administrative Clerk
Found in: Jooble US O L C2 - 3 days ago
Stanford University Stanford, CA, United StatesStanford University is seeking an Administrative Associate 3 to provide administrative support working under general supervision in the Department of Radiation Oncology, Division of Radiation and Cancer Biology. The AA will report directly to the Division Manager in the Departmen ...
-
Assistant Clinical Research Coordinator
Found in: Lensa US 4 C2 - 1 day ago
Stanford University Stanford, United StatesAssistant Clinical Research Coordinator (Hybrid) · **School of Medicine, Stanford, California, United States** · Research · Post Date Mar 28, 2024 · Requisition # 102712 · The Division of Radiation & Cancer Biology in the Department of Radiation Oncology is seeking an Assistant C ...
-
clinical pharmacist ii
Found in: MyJobHelper US C2 - 2 days ago
Lucile Packard Children's Hospital Stanford Palo Alto, CA , USA, United StatesPharmacy · 1.0 FTE, 8 Hour Rotating Shift · At Stanford Children's Health, we know world-renowned care begins with world-class caring. That's why we combine advanced technologies and breakthrough discoveries with family-centered care. It's why we provide our caregivers with con ...
-
clinical pharmacist ii
Found in: MyJobHelper US C2 - 2 days ago
Lucile Packard Children's Hospital Stanford Palo Alto, CA , USA, United StatesPharmacy · 1.0 FTE, 8 Hour Rotating Shift · At Stanford Children's Health, we know world-renowned care begins with world-class caring. That's why we combine advanced technologies and breakthrough discoveries with family-centered care. It's why we provide our caregivers with con ...
-
clinical pharmacist ii
Found in: MyJobHelper US C2 - 2 days ago
Lucile Packard Children's Hospital Stanford Palo Alto, CA , USA, United StatesPharmacy · 1.0 FTE, 8 Hour Rotating Shift · At Stanford Children's Health, we know world-renowned care begins with world-class caring. That's why we combine advanced technologies and breakthrough discoveries with family-centered care. It's why we provide our caregivers with con ...
-
executive assistant
Found in: MyJobHelper US C2 - 2 days ago
Guardant Health, Inc. Palo Alto, CA , USA, United StatesGuardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patie ...
-
Cancer Diagnostics Product Director
Found in: Lensa US 4 C2 - 1 day ago
Guardant Health Palo Alto, United StatesCompany Description · Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial ...
-
Senior Manager, Demand Generation
Found in: Lensa US 4 C2 - 4 days ago
Guardant Health Palo Alto, United StatesCompany Description · Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial ...
-
associate director, healthcare compliance
Found in: MyJobHelper US C2 - 2 days ago
Guardant Health, Inc. Palo Alto, CA , USA, United StatesGuardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patie ...
-
Pharmacy Technician
Found in: Lensa US P 2 C2 - 6 days ago
Sutter Health Palo Alto, United States Paid WorkOrganization: · PAMF-Palo Alto Medical Foundation PAD · Position Overview: · Provides timely and accurate pharmaceutical care. Prepares, compounds, packages, labels, and dispenses medication, nutritional products, IV admixture and solutions (e.g., chemotherapy, biotherapy, etc.), ...
-
Senior Manager, Demand Generation
Found in: Jooble US O C2 - 4 days ago
Guardant Health Palo Alto, CA, United StatesCompany Description · Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial ...
-
Director, Medical Partnerships
Found in: Jooble US O C2 - 4 days ago
Varian Medical Systems, Inc. Palo Alto, CA, United StatesAt Varian, a Siemens Healthineers Company, we bring together the world's best talent to realize our vision of a world without fear of cancer. Together, we work passionately to develop and deliver easy-to-use, efficient oncology solutions. · We are part of an incredible community ...
-
Cancer Diagnostics Product Director
Found in: ZipRecruiter Test10P US C2 - 1 day ago
Guardant Health Palo Alto, United StatesJob Description · Job DescriptionCompany Description · Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages c ...
Senior Manager, Clinical Trial Supplies, Oncology - Stanford, United States - Ascendis Pharma
Description
Here 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:
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.
Benefits
