Our client, an emerging clinical stage pharmaceutical firm, is seeking a Manager, Clinical Operations to support the development of the Clinical Operations infrastructure and ensure high quality standards and timeliness of implementation and completion of clinical trials. The Manager oversees operational aspects of all clinical studies within assigned territories and/or worldwide and provides strategic direction for clinical trial operations through the direct line-management of the clinical research staff. The Clinical Operations Manager is responsible for the development and implementation of clinical research processes and systems. This position is DIRECT HIRE and comes with excellent benefits and compensation.
To perform this job successfully an individual must be able to perform each essential function satisfactorily.
• Directly supervise the execution of all of client’s clinical trials
• Manage interactions with outside consultants, vendors and other groups
• Oversee the activities of the Clinical monitoring team to support overall project management timelines:
o Coordinate the smooth monitoring of all trials by identifying and managing qualified staff, assuming appropriate managerial oversight of CRA staff , establishing audit procedures, and ensuring that cleaned data are entered into the database in a timely fashion
o Review and approve monitoring visit reports, regulatory documents, and other key study records
o Develop systems for the tracking of projects, including site information, IRB/IEC information, study progress, subject recruitment activities, and other clinical trial materials, as needed
o Assist in the preparation of protocols and Case Report Forms, monitoring and data management tools and other study documents
• Will contribute to the review and revision of Clinical documents (e.g., protocols, study reference manuals, documents to be submitted to Regulatory agencies or ethics boards), Standard Operating Procedures, guidelines, and departmental policies.
• Develop and implement team training activities to ensure compliance with ICH GCP, regulatory requirements, study protocols and SOPs.
• Interact with other team members - participate in meetings and ensure that team(s) are aware of relevant issues
• Will work directly with the Clinical Project Manager/Director to oversee project timelines and vendor activities.
• Will interact directly with other Clinical Managers, CRAs and Investigators to relay key study issues, status updates, and other study information.
• Will coordinate vendor meetings and review vendor documents (e.g., manuals) for adequacy.
• Will be required to lead and supervise staff involved in clinical trials, including internal staff members and external consultants and vendors.
• Bachelor's degree in biomedical, life science or related field of study.
• Minimum of 6-8 years pharmaceutical, biotechnology or CRO clinical research experience.
• Experience in overseeing clinical monitors (CRAs), consultants.
• Knowledge of GCPs, ICH guidelines and FDA regulations. Familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements is a plus.
• Must possess a professional demeanor and effective communication capabilities for collaboration with others in a multi-disciplinary group.
• Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressures.
• Adaptable and able to work in a work environment where priorities are constantly changing.
• Ability to effectively present ideas and document concepts in writing and orally.
• Excellent computer literacy with working knowledge of PCs, Windows and Microsoft Office applications.
• Ability to travel, in some cases, internationally.