Job Description / Position Description
Sr Clinical Operations Study Leader - Early Development Oncology is a senior member of the Clinical Operations team. This position is primarily a tactical study delivery role, reporting into a Director (or above) responsible for Early Development Operational Study Strategy and delivery. The highly experienced early development Sr. Study manager – will be responsible for the management of one or two… very complex First in Human Or Phase I/II early development Oncology patient Studies. This position may require both Early Development Oncology (patient study) operational strategy development and Early Development Oncology study execution.
- Clinical Operations Study leader leading the Operational execution of a PhI or PhII early development complex oncology patient study.
- Supporting or leading strategic country & site selection and vendor setup based on complexity of the study and taking into consideration of the competition and competing molecular targets.
- Conduct Study feasibility and site/lab assessments, providing recommendation of suitable sites for selection to participate in the trial. Ensure appropriate follow-up of pre-trial visit reports.
- Collaborate with the Clinical Practice Leader (CPL), GTL, country TMs (if applicable), functional management and Protocol Owner to select final site list.
- Contribute input to the development of the Safety Monitoring Plan, Filing and Archiving Plan and Investigational Product documents at a country level or initiates development of these plans for trials to which no GTM is assigned.
- Lead and coordinate local trial team(s) activities in compliance with SOPs, WIs and applicable regulations. Lead project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget, including but not limited to, development of trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
- Ensure that all Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within reporting timelines and documented as appropriate.
- Maintain and update trial management systems (e. g. eTMF, Trial Master Source and SharePoint sites).
- Monitor country and overall study progress (if applicable) and initiate Corrective and Preventive Actions (CAPAs) when the trial deviates from plans and communicates study progress and issues to CPL, GTL, protocol owner and study management teams. Ensure appropriate documentation and follow-up related to protocol issue escalation.
- Lead and coordinate negotiation of trial site contracts and budgets as needed.
- Accountable for set-up and conduct of Investigator Meetings (either local or multi-country).
- Conduct trial team meetings and provide or facilitate Trial Manager (TM)/Site Manager (SM) training when needed.
- Review and approve Monitoring Visit Reports submitted by SM, which identifies issues and/or trends across a trial project and escalates deviation issues to the GTL and Functional Manager (FM) as needed.
- Work with TMs/SMs to ensure CAPAs are developed and implemented for audits and inspection or any quality related visits.
- Act as primary local or multi-country contact in GCO for a trial. Establish and maintain excellent working relationships with external stakeholders, such as investigators, trial coordinators, other site staff, key contacts in ED&CP; and other internal stakeholders.
- Actively contribute to process improvement initiatives, and training and mentoring of SMs, Clinical Trial Assistants (CTAs) and other TMs.
The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. A key focus will be the oversight of and interactions with CROs and other external vendors to ensure studies are conducted according to the timeline, budget and objectives set forth by the Study team
- A minimum of BS or completion of a Nursing Program (RN) is required. A Bachelor s degree in a Health or Science discipline is preferred. Advance degrees are preferred.
- A minimum of 10 years of clinical research/clinical trial experience within the Pharmaceutical, Clinical Research Organization (CRO) and/or Biotech industries is required.
- At least 5 years in leading clinical operations teams in Oncology patient studies. (IRR & ISS studies will not be considered)
- At least 2 years in Early Development Oncology PATIENT Studies and Clinical Pharmacology.
- Previous experience leading an Oncology Patient study from start to finish which supported an NDA filing is preferred
- Previous demonstrated experience working with CROs working on oncology clinical operations patient studies.
- Strong knowledge of the drug development process, including International Council on Harmonization (ICH)/Good Clinical Practices (GCP), and local regulatory requirements required.
- Experience working with computer software applications required.
- Experience with clinical systems preferred.
- Must have excellent oral and written communication skills.
- Must have strong leadership skills.
- The ability to work at a fast pace within small exploratory study teams is required.
- This position will require up to 20% travel.
- Clinical Operations
- Clinical Pharmacology
- Clinical Research
- Clinical Systems