Sr. CTM / Clinical Trial Manager

Sr. CTM / Clinical Trial Manager

W2 Contract-to-Hire

Salary Range: $166,400 - $187,200 per year

Location: Redwood City, CA - Onsite Role

Job Summary:

This is a unique opportunity for a Clinical Trial Manager (CTM) / Sr. Clinical Trial Manager (Sr. CTM). You will be responsible for acting as an integral member of the clinical study team(s) and will be tasked to support the execution and management of clinical trials. Reporting to the Director you will play a critical role in ensuring trials and studies align with all applicable standards.

Duties and Responsibilities:

• Adhere to Clinical Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and International Conference on Harmonization (ICH) Guidelines.
• Provide guidance and oversight for the successful management and completion of delegated aspects of clinical trials within designated program budgets and timelines.
• Review and contribute to the development of study-specific documents and reports (e.g., essential documents, plans, training materials, study guides, manuals, etc.).
• Ensure proper oversight of the clinical trial by thorough review of vendor agenda/meeting minutes, sampling of monitoring report oversight review, study drug accountability review, monitoring oversight, and ensuring issues are resolved/addressed in a timely manner.
• Oversight of operational colleagues' activities as it relates to clinical trial document activities (e.g., collection, management, verification, filing, etc.) and ensuring the Trial Master File (TMF) is inspection-ready.
• Follow up and follow through on team action items and identification, escalation, and resolution of issues as needed.
• Prepare, track, review, and analyze for trends study participant projections vs actuals (e.g., participant enrollment, assessments).
• Identify, engage, and manage the activities of contract research organizations (CROs) and other clinical trial vendors (e.g., Interactive Response Technology (IRT), imaging vendor, central labs, etc.) as well as serve as liason between internal team members, investigative sites, and CROs.
• Support the study lead in the management of clinical study timelines and budget by utilizing appropriate project management tools, identify and select vendors, manage vendor contracts, and ensure budgets are within department guidelines.
• Co-lead team meetings and collaborate with cross-functional groups within the clinical study team (e.g., Clinical Data Science, Clinical Development, Pharmacokinetics, Regulatory, etc.) to achieve clinical trial goals.
• Follow up and follow through on team action items and identification, escalation, and resolution of issues as needed.
• Assess adequacy/feasibility of potential clinical investigators and sites, including qualification of investigators, evaluation of facilities, personnel, patient referral base, and adherence to GCP.
• Review and identify trends when performing routine data surveillance of data listings, and support in the preparation of interim and final Clinical Study Reports and resolution of data discrepancies.
• Provide support, mentorship, guidance, and direction to Clinical Trial Assistants (CTAs) and Clinical Trial Management Associates (CTMAs), as appropriate.
• Actively contribute in development of internal business documents (e.g. SOPs, Clinical Study Reports, Investigational New Drugs (INDs), New Drug Applications (NDAs), and other Clinical, Regulatory, Safety documents) with minimal supervision.
• Support other Clinical Operations activities as appropriate.

Requirements and Qualifications:

• RN or Bachelor's degree in biological sciences or a health-related field required.
• 5+ years (CTM) or 7+ years (Sr. CTM) direct experience preferred and/or relevant experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research-related experience.
• Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP.
• Experience in selection of CROs/vendors and management of external resources.
• Thrives in a collaborative team setting that demonstrates flexibility required to maintain a fast pace and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
• Excellent written/verbal communication and interpersonal skills.
• High sense of priority and commitment to excellence in the successful execution of deliverables.
• Ability to analyze operational data, perform with an emphasis on quality, timeliness and multi-task, prioritize tasks, anticipate challenges, and execute on goals as a member of an interdisciplinary team.
• Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.
• Travel may be required (~15%).

Preferred Qualifications:

• Decision-making skills
• Has familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).
• Oncology experience, early and/or late stage, strongly preferred.
• Knowledge and/or familiarity with EMEA/APAC region(s) clinical trial operations.
• Attention to detail.

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

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