Sr Mgr, Clin Operations (DG)

Date Posted: 10/20/2023

Senior Manager, Clinical Operations
Oncology or Neurology
Bergen, NJ (Remote)

The Senior Manager, Clinical Operations will lead the cross-functional study team in managing one or more international clinical studies in Oncology, from Protocol Concept to Clinical Study Reporting and Disclosure. This is an exciting opportunity for an individual with a proven track record of leading international study teams, including internal cross-functional coordination, CRO and vendor management to join a dynamic team working to deliver high quality Oncology studies to time and budget. The role is key to ensuring that study milestones and deliverables are achieved according to agreed quality standards and timelines and that quality of data are acceptable and suitable for regulatory submission. This individual ensures that assigned studies are executed according to ICH/GCP guidelines, applicable regulatory requirements, and standard operating procedures. Additionally, the Senior Manager manages performance and development of assigned direct report(s).

RESPONSIBILITIES:
Managing all aspects of study progress from start-up to close-out activities and end of study reporting. Preparing detailed project plan(s) with cross-functional input for all phases of the clinical study, assuring adherence to intended timelines to achieve study goals while ensuring compliance with international GCP guidelines & regulations and SOPs/SWPs , identifying risks, procuring adequate resources, and implementing risk mitigation plans. Coordinating interdisciplinary activities throughout the study. Oversight and management of CRO and clinical vendors to ensure successful conduct of the clinical trial and to ensure data integrity and quality. Effective communication with KOLs and Investigator site staff to support study delivery. Contributing to individual and team development through training initiatives and team building activities. Manages performance and development of assigned direct report(s).

REQUIREMENTS:
Bachelor’s degree in biological science, nursing, pharmacy or equivalent as a minimum. Minimum 5 years of experience in the pharmaceutical industry in a position performing clinical operations functions as a clinical trial or clinical study manager. Proven track record as a clinical study manager leading international study teams, including internal cross-functional coordination and CRO and vendor management to deliver high quality Oncology studies to time and budget. Previous pharma industry experience in Oncology, including awareness of current anti-tumour therapies is essential, and the individual should be at ease with tools such as RECIST criteria for tumour assessment and NCI Common Toxicity Criteria. Demonstrated experience in the identification of emerging risks and the ability to collaboratively champion solutions within a multi-disciplinary drug development team to help resolve challenges. Must possess excellent project planning and priority setting skills, as well as excellent organizational and interpersonal skills and flexibility to accommodate to rapidly changing priorities and deadlines. Solid project and vendor management, analytical and problem-solving skills. Prior experience with development, tracking and reconciliation of study budgets. Excellent written and verbal communication skills. Proficiency in MS Office, including MS Project. Line management experience is strongly preferred.

Please contact Darren Gutowski at dgutowski@clarkdavis.com