Manager, Clinical Operations

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.

Education:

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.

Experience/Requirements:

  • 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:
https://workforcenow.adp.com/mascsr/default/mdf/recruitment/recruitment.html?cid=d6149cc3-4b20-4b4b-8715-9d6e5dc7b7e1&ccId=19000101_000001&jobId=171471&lang=en_US&source=CC4