The Manager, Clinical Operations is responsible for coordinating, providing oversight and managing a variety of clinical trials. These trials require prioritization, initiation, planning, management and closure.
Oversee the daily operations for clinical trials, including but not limited to:
- Participates in the design and review of clinical protocols, CRFs, ICFs and other associated clinical trial documents/plans, regulatory submissions and reports in collaboration with the clinical team.
- Participates in the identification, evaluation and selection of investigators, sites and vendors.
- Serves as the primary point of contact, assists in managing and provides guidance for project specific CROs and vendors; assists and/or manages activities and interactions with CROs and /or other vendors.
- Participates in preparation, management of and participates in Investigator Meetings, as applicable.
- Assesses and addresses clinical trial start up issues with internal and/or CRO teams as applicable.
- Performs assessments and ensures adherence to protocols, procedures and project plans.
- Oversee clinical site monitoring activities and may participate in site monitoring as needed associated with qualification, initiation, interim, close-out and audit visits.
- May perform co-monitoring and oversight visits at participating sites, CROs, clinical labs, etc., to ensure compliance with appropriate regulations, guidelines and policies.
- Serves as a resource within the team for expedited problem identification and resolution, provision of site/study specific updates, CRO interactions and deadlines
- May oversee and coordinate subject recruitment/retention strategy and related initiatives.
- May review and provide guidance on monitoring visit reports from CROs as needed to ensure applicable regulatory and protocol compliance, issue resolutions as well as quality site management and reporting.
- Reviews and works with CRO team to ensure TMFs remain current throughout the conduct of assigned clinical trials.
- Adheres and assists with clinical and CRO project specific quality documents (SOPs, work instructions/plans and training guides).
- Provides regular clinical status information.
- May review data and resolution of queries; assists in data review and the preparation of reports as needed.
- Ensure all essential documentation and communications is maintained as part of the clinical files.
- Travel as needed, domestic and international, up to 40%.
- May perform other related duties as required and/or assigned.
BS or RN degree in a relevant scientific discipline or a related field, or equivalent education and experience. Experience substituted for a degree must be highly applicable to the role.
- Requires a minimum of 7 years relevant experience with clinical trials in a sponsor, biotech, pharma or CRO setting. Demonstrates a broad understanding of clinical operations.
- Strong working knowledge of medical scientific terminology, knowledge of FDA Regulations and ICH/GCP Guidelines.
- Experience with ex-US trials and an understanding of regulatory requirements other than the FDA preferred
- Excellent organizational and project management skills including teamwork, problem solving, customer service and presentation skills.
- Ability to coordinate or manage multiple projects across multiple centers/countries.
- Ability to work effectively with vendors and personnel at clinical sites.
- Ability to handle basic protocol/project issues with minimal guidance
- Experience with electronic data capture systems preferred.
- Experience with cross-functional project flow (i.e. finance, project management, ancillary teams).
- Good organizational skills, attention to detail and ability to prioritize tasks to meet critical timelines.
- Knowledge of clinical plans and their corresponding critical path.
- Strong oral and written communication skills.
- Strong software and computer skills.
- Ability to establish and maintain effective working relationships with co-workers, managers and clients.
- Must be able to travel, including potential international travel.
Equal Opportunity Employer/Females/Minorities/Veterans/Disability
Apply for Manager, Clinical Operations using the link below: