Senior Manager, Clinical Trials- Radiopharmaceuticals - Paramus, NJ

Overview: · The SCTM (Senior Clinical Trial Manager) supporting Radiopharmaceuticals will be independently responsible for ensuring the execution of more complex clinical studies in one or more geographic regions in Phases I–IV, in adherence to Good Clinical Practices (GCPs), app ...

Job description

Overview:

The SCTM (Senior Clinical Trial Manager) supporting Radiopharmaceuticals will be independently responsible for ensuring the execution of more complex clinical studies in one or more geographic regions in Phases I–IV, in adherence to Good Clinical Practices (GCPs), appropriate SOPs, FDA regulations/EU Directive, and ICH guidelines. The role will support studies that include radiopharmaceutical and imaging components and requires familiarity with the associated operational and regulatory considerations.

The SCTM will perform these responsibilities under the leadership of the Senior Director of Clinical Operations, Clinical Pharmacology Lead, and Executive Medical Director.

The SCTM will have routine interaction with key internal and external stakeholders communicating project status, escalating issues, reporting appropriate study metrics, and providing day-to-day oversight of CROs and vendors. Proficient written and verbal communication skills, strong decision-making abilities, clinical project management skills, and attention to detail are required and equally important.

Responsibilities:

Study Management & Leadership

• Has primary accountability for operational study-level time, cost, and quality deliverables with a global, more complex aspect, including studies involving radiopharmaceuticals and/or imaging agents.
• Oversees day-to-day supervision of clinical trial execution, with a focus on site start-up, patient enrollment, monitoring, compliance, and data flow metrics from clinical sites, CROs, and appropriate vendors, ensuring appropriate coordination of radiopharmaceutical, imaging, and radiation-related activities.
• Lead document review and coordination for the protocol and amendments. Additional review/coordination may involve ICF, IRB/EC applications/responses, CRF, and all appropriate study plans, including radiopharmaceutical-specific or imaging-related sections as applicable.
• Lead the CRO and vendor selection process in collaboration with the study team and outsourcing vendor, including vendors supporting radiopharmaceutical manufacturing, imaging services, or specialized logistics, and present findings for management approval.
• Lead trial feasibility and site identification activities in collaboration with the CRO and study team, while factoring in global regulatory strategy, including assessment of site capabilities for radiopharmaceutical handling and imaging procedures.
• Lead Study Management Teams (SMTs) for internal SKLSI teams and external SMTs with CROs, ensuring all functions provide functional expertise and appropriate follow-up, including coordination with imaging, nuclear medicine, or radiopharmacy stakeholders when applicable.
• Participate in investigator meetings, kick-off meetings, monitor trainings, and various CRO or vendor meetings, including radiopharmaceutical and imaging-related training sessions.

CRO, 3rd Party Vendor Management and Oversight / Budget

• Responsible for oversight, performance, and management of CROs and third-party vendors to ensure compliance with SKLSI SOPs and adherence to scope of work, timelines, and budget at a task level, including vendors supporting radiopharmaceutical production, imaging, or radioactive material logistics.
• Track operational study timelines and monitor performance metrics through the life of the study; identify issues and propose solutions, including those related to radiopharmaceutical supply or imaging execution.
• Ensure CROs provide timely input and generate high-quality documents per protocol and study plans, including radiopharmaceutical-related operational deliverables.
• Oversee CRO study start-up activities and coordinate with functional groups to ensure essential site documents are collected and sites are initiated per study plan, including radiation safety documentation and imaging readiness, where required.
• Oversee and track site initiation and enrollment activities at the country and site level and develop mitigation strategies in collaboration with the CRO, considering radiopharmaceutical availability and imaging capacity.
• Coordinate with CROs to prepare and execute meetings including vendor kick-off meetings, study team meetings, investigator meetings, and study training.
• Ensure adequate forecast, management, and accountability of drug supply in collaboration with the SKLSI Clinical Supply group, including planning for radiopharmaceutical manufacturing, labeling, distribution, and time-sensitive delivery.
• Identify and mitigate potential study risks and develop internal strategies, including risks associated with radiopharmaceutical operations and regulatory requirements.
• Ensure study invoices are in line with Scope of Work; review change orders and coordinate with outsourcing vendors, SKLSI Finance, and relevant functions to ensure study forecast transparency and milestone alignment.

Qualifications:

• A Bachelor's degree (preferred in Life Sciences) is acceptable.
• 5-6 years' relevant clinical trial experience
• Thorough knowledge of GCP/ICH, clinical trial design, , regulatory processes, and global clinical development process
• Experience supporting radiopharmaceutical and/or imaging-based clinical studies is required. Familiarity with radiation safety, imaging operations, or radiopharmaceutical supply considerations is an asset.
• Ability to multitask
• Adapts to change
• Maintain composure under pressure
• Ability to follow verbal or written instructions and use of effective verbal communications
• Grasps information quickly
• Examine and observe details
• Approximate 15% travel for investigator meetings