- Services rendered will adhere to applicable SOPs, WIs, policies, local
- Leads the cross-functional Trial Team, tracking of project deliverables and timelines using functional planning tools and support. Proactively manages that trial deliverables and milestones are met. Identifies risks and ensures mitigation and contingencies are being initiated and followed through (including management of CAPAs).
- Accountable for delivery of global trials within agreed/projected life of trial budget. Ensures accurate trial budget management, updates for scope changes and reconciliation of assigned trials for both Out of Pocket (OOP) costs and FTE costs. Is responsible for overall contract management, including review & approval of external service provider (ESP) contracts, change orders and ensures services are delivered per contract.
- Ensures that environmental analysis, protocol feasibility and country & site selection process is conducted within agreed timelines. Responsible to drive the final study placement and ensures alignment with and communication to the involved stakeholders, including TA and feasibility leads.
- Develops the trial ESP strategy for assigned trial(s) in line with the overall program ESP strategy.
- Is accountable for oversight of all external service providers for both inhouse and outsourced studies. Is responsible for vendor selection and set up, including scope of work and specifications in line with protocol requirements, budget and timelines. During execution, the GTL will ensure escalated vendor issues are appropriately resolved. For outsourced trials is responsible for management, including initiation of selection process, SOW development, budget and change orders and oversight of all deliverables outsourced to the CRO. Is primary point of contact for the assigned Project Director/Manager from the CRO responsible for the trial.
- Ensures that the trial is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes. Participates in preparation for, and conduct of, Health Authority inspections and internal QA audits. Ensures that the Trial Team operates in a constant state of inspection-readiness. Collaborate with Bioresearch Quality and Compliance liaisons to ensure quality oversight of assigned trial utilizing the available tools.
- Ensures appropriate trial-specific training is provided to the trial team members; in collaboration with the Study Responsible Physician (SRP). Oversee the Clinical Trial Manager (CTM) in the set[1]up and coordination of Investigator Meetings, if applicable.
- Ensures transparent status reporting information to relevant key stake holders in R&D.
- Ensure trial related issues (quality, timelines, budget, resources) are resolved within the function and/or within the Trial Team and if they can't be resolved within the function and/or Trial Team they are escalated to the GPL and Clinical Team level, as necessary. Manages timely and accurate documentation of issue escalation. Drive lessons learned initiatives at trial level during and after trial milestone completion; accountable for developing subsequent issue resolution and process improvements as required.
- Partners closely with the team members from Therapeutic Area, other GCDO functions, Clinical Supply Chain, Bioresearch Quality and Compliance Group, Clinical Business Operations, Finance, Project Management Organization, Regulatory and external partners, to influence alignment on issues and decisions affecting trial management, enabling successful trial outcome
- Program/TA specific activities (to be specified). Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP) document.
- Bachelor's degree or equivalent, preferably in Life Sciences.
- Minimum of 8 years of clinical trial experience in the pharmaceutical industry or CRO.
- Requires in-depth clinical research operational knowledge, strong project planning/management, communication and presentation skills. Must have the ability to manage all aspects of execution of a clinical trial. Experienced and proven track record of success in managing or leading global or regional teams in a virtual environment is required. Strong expertise in vendor management.
- Excellent leadership skills and proven ability to foster team productivity and cohesiveness.
- Specific therapeutic area experience and skills depending on the area of support.
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Director of Oncology Practice and Education
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Odell Medical Search Durham, United StatesCancer Network along the east coast that is seeking a Director of Oncology Practice and Education toprovide consultative support and education for 10+ cancer program across 5 states. The role you will play- Provide consultative support focused on quality oncology patient care inc ...
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GlaxoSmithKline Durham, United StatesSite Name: USA - Pennsylvania - Upper Providence, Durham Blackwell Street, USA - Pennsylvania - Philadelphia · Posted Date: May 6 2024 · Are you interested in a leadership opportunity to drive the implementation of effective Clinical Oncology strategies for a multi-national pharm ...
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IQVIA Durham, United States**Overview:** · This role provides global operational leadership for the cross-functional delivery of assigned trial(s), within agreed timelines and budget and in alignment with all applicable SOPs and regulatory requirements, in alignment with the organizational and therapeutic ...
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UNC Health Care Chapel Hill, United States**Description** · Become part of an inclusive organization with over 40,000 diverse employees, whose mission is to improve the health and well-being of the unique communities we serve. · Summary: · The Director of Pharmacy will develop, oversee and maintain high-quality, cost-eff ...
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Odell Medical Search Durham, NC, United StatesCancer Network along the east coast that is seeking a Director of Oncology Practice and Education toprovide consultative support and education for 10+ cancer program across 5 states. The role you will play- Provide consultative support focused on quality oncology patient care inc ...
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Surgery Research
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Shattuck Labs, Inc. Durham, United StatesAbout the position: · The Associate Director/Director of Clinical Research, in collaboration with the Medical Monitor, is responsible for the design, conduct, analysis, and reporting of clinical trials. This individual will assume a lead role in trial planning and execution, work ...
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Xilis Durham, United StatesXilis, Inc. is an innovation-driven biotech company developing its proprietary MicroOrganoSphere ("MOS") Technology for functional precision oncology. Xilis' MOS Technology enables rapid and scalable generation of patient tumor models that retain patient-specific tumor biology an ...
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Xilis Durham, United StatesRole · We are looking for a motivated and innovative scientist / sr. scientist to join our growing team to execute critical experiments. In this role, the scientist / sr. scientist hired will support collaborative projects with biotech and pharma companies and academic institutio ...
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Labcorp RTP, United StatesAre you an experienced Medical Lab Professional? Are you looking to embark on a new challenge in your career, or start your career in Medical Lab Science? If so, LabCorp wants to speak with you about exciting opportunities to join our team as a **Technologist Trainee** in **RTP, ...
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Duke Health Durham, United States Full timeThe Department of Pathology at Duke University Medical Center is seeking a full-time faculty member in the role of Assistant Director of Clinical Microbiology for Duke University Health System Clinical Laboratories and Assistant or Associate Professor in the Department of Patholo ...
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SHATTUCK LABS, INC. Durham, United StatesJob Description · Job DescriptionAbout the position: · The Associate Director/Director of Clinical Research, in collaboration with the Medical Monitor, is responsible for the design, conduct, analysis, and reporting of clinical trials. This individual will assume a lead role in ...
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NeoGenomics Laboratories Durham, United StatesAre you motivated to participate in a dynamic, multi-tasking environment? Do you want to join a company that invests in its employees? Are you seeking a position where you can use your skills while continuing to be challenged and learn? Then we encourage you to dive deeper into t ...
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Shattuck Labs, Inc. Durham, United StatesJob Description · Job Description · About the position: · The Associate Director/Director of Clinical Research, in collaboration with the Medical Monitor, is responsible for the design, conduct, analysis, and reporting of clinical trials. This individual will assume a lead role ...
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Director, Medical Strategy and Capabilities
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GlaxoSmithKline Durham, United StatesSite Name: USA - Pennsylvania - Philadelphia, Durham Blackwell Street, Upper Providence · Posted Date: Apr · GSK site preferred locations: Philadelphia Walnut Street, PA, Upper Providence, PA, Durham, NC. On-site presence of 2-3 days per week average is anticipated. Additional f ...
Clinical Project Management Director, Oncology - Durham, United States - IQVIA
Description
Overview:
This role provides global operational leadership for the cross-functional delivery of assigned trial(s), within agreed timelines and budget and in alignment with all applicable SOPs and regulatory requirements, in alignment with the organizational and therapeutic area (TA) Clinical Team (CT)'s objectives.
Services/deliverables include the global accountability and operational oversight of both internally managed and outsourced trials, covering the end-to-end project management including start[1]up, execution, close-out, analysis and reporting.
In this role, you will be responsible for leading the cross-functional Trial Team and partners with all trial team members, building the trial operational plan and responsible for External Service providers' (ESP) contracts and budget.
Deliverables:
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry.
We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world.
Learn more atWe are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities.
IQVIA's ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status.
The potential base pay range for this role, when annualized, is $117, $263, The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time).
Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
Clinical Project Management Director, Oncology professionals in Durham
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Sami Shaban
Medical Laboratory Supervisor