Sr. Clinical Operations Lead

• Participate as a member of a working group and perform special projects, as assigned, to improve the efficiency, effective and quality of the functioning of the Development Operations department. 

• Act as preliminary liaison for study sites to convey study information, answer questions and in accordance with the escalation pathway. 

• Develop relationships with investigational sites, HCPs, and institutions to enhance conduct of the trial. 

• Monitor study-specific timelines and key deliverables; focus on management of all relevant external vendors (e.g., Monitoring, Sample management, IVRS, Laboratory, etc). Participate as a member of the multi-disciplinary trial(s) team. 

• Participate in coordinating efforts with internal Pharmacovigilance, and safety group as needed. 

• Participate in data review and discrepancy resolution as needed. 

• Assist in the development of the IP and co-medication strategy (quantities, labels, depots, tracking, etc.) working closely with other departments. 

• Plan and organize meetings with team support (e.g., investigator/coordinator meetings, DMC, SMC, safety call, etc.) as appropriate. 

• Assist in the development and management of study timelines and priorities, including recruitment tools/strategy. 

• Coordinate and monitor activities at investigational sites; review monitoring trip reports and support the US monitoring organization as appropriate. 

• Participate in the feasibility and evaluation of investigative sites as needed, working closing with the Clinical Trial Logistics group. 

• Create Master ICF template and review/approve site changes (in consultation with legal, safety when warranted). Update template for new risks and new amendments information. 

• Assists in the review, development and writing of study documents and manuals, including but not limited to study manuals, treatment guidelines, patient access forms, laboratory or biomarker plans, and other supporting documents. 

Minimum Requirements 

• BS/BA degree or a relevant degree with strong emphasis on science, or equivalent experience  

• Minimum of five years of relevant experience in the biopharmaceutical industry or other relevant clinical research experience, with a focus on skills and competencies. 

• Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health 

• Prior experience in assisting the conduct and management of multinational clinical trials is preferred. 

• Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously. 

• Experience in oncology studies required (phase I preferred)