Clinical Program Manager, Clinical Operations Excellence

W2 Contract

Pay Rate: $100 - $110 per hour

Location: Redwood City, CA - Remote Role

Job Summary:

This is a unique opportunity for a Clinical Operations Professional. As a Clinical Program Manager, Clinical Operations, Clinical Operations Excellence (CORE), you will be responsible for the development and implementation of processes to contribute to Clinical study quality and inspection readiness.

Duties and Responsibilities:

• Using knowledge of and experience with successful clinical study management activities, and strong knowledge of Clinical Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), and International Conference on Harmonization (ICH) Guidelines, you will be responsible for developing and managing clinical study quality processes and tools to facilitate study team compliance.
• Contribute to the development and management of processes and systems that will facilitate clinical trials to maintain an inspection readiness state throughout the lifecycle of the trial.
• Partner with Clinical Operations and cross-functional team members to develop or improve processes that will impact clinical trial management, quality, and efficiency.
• Drive consistency in processes and tools across studies.
• Contributes to the development of RFPs and participates in the selection of CROs/vendors.
• May be asked to train Clinical Operations or cross-functional team members on processes or requirements.
• Responsibilities may include development and management of processes for study monitoring oversight activities, and vendor oversight activities such as clinical study vendor SOP review.
• Responsibilities may include the development and management of central clinical trial status information, tracking, and reporting.
• May lead or participate in interdepartmental strategic business initiatives as well as spearhead or contribute to SOP development and training.
• Participate in the recruiting and hiring process.
• Mentor and train CORE team members such as Clinical Trial Managers (CTMs), Clinical Trial Management Associates (CTMAs), and Clinical Trial Assistants (CTAs).
• Partner within Clinical Operations and with Clinical Operations Compliance and CQA on remediation of quality issues and implementation of continuous improvement initiatives.
• Conduct risk management, contingency, and scenario planning.
• Participate in other Clinical Operations Activities as appropriate.

Requirements and Qualifications:

• An RN or a bachelor's degree in biological sciences or a health-related field is required.
• 8+ years direct Clinical Operations or a combination of Clinical Operations and Clinical Quality Assurance experience in the pharmaceutical or biotech industry. Relevant indirect experiences may also meet the requirement.
• Expert knowledge of FDA and EMA Regulations, ICH Guidelines, and GCPs, and familiarity with Standard clinical operating procedures.
• Demonstrated experience successfully developing and authoring Clinical Operations and cross-functional SOPs or Clinical study process templates in support of clinical study management, oversight, and inspection readiness.
• Experience with the development and implementation of study vendor and monitoring oversight activities.
• High-level cross-functional collaboration; strategic thinking across trials and functions.
• Strategic thinking across clinical trials and functions with strong program-level planning and risk management.
• Thrives in a collaborative team setting that demonstrates the flexibility required to maintain a fast pace and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
• Be solution-oriented by anticipating obstacles and difficulties and proactively providing risk assessment and mitigation strategies to achieve project goals.
• Ability to deal with time demands, incomplete information, or unexpected events.
• Outstanding organizational skills with the ability to multitask and prioritize.
• Excellent interpersonal, verbal, and written communication skills.
• High sense of priority and commitment to excellence in the successful execution of deliverables.
• Ability to review and assess vendor SOPs for alignment with and/or gaps compared to sponsor SOPs and study documents.
• Ability to communicate with Clinical Operations and cross-functional team members across study teams to assure compliance with company SOPs and processes, and FDA Regulations, ICH Guidelines, and GCP.
• Ability to contribute with a mind on quality, diligence, timeliness, and fiscal responsibility, make and drive decisions, multitask, prioritize tasks, anticipate challenges, and execute goals as a member of the Clinical Operations Excellence team.
• Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.
• Travel may be required (~25%).

Preferred Qualifications:

• Decision-making skills.
• Familiarity working with systems/portals (e.g., eTMF, EDC, IRT, CTMS).
• Oncology experience, early and/or late stage, strongly preferred.
• Experience in start-up, management, and close-out clinical trials.
• Experience conducting onsite monitoring.
• Knowledge and/or familiarity with Ex-US region(s) clinical trial operations.
• Familiarity and experience with managing risk-based monitoring.
• Experience working within Veeva Quality Documents and Quality Management Systems or similar systems.

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate. 

Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at www.baysidesolutions.com.