Bayside Solutions
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Base pay range
$80.00/hr - $90.00/hr Senior Clinical Trial Manager
W2 Contract-to-Hire Salary Range:
$166,400 - $187,200 per year Location:
Redwood City, CA - Hybrid Role Job Summary
This is a unique opportunity for a 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 into the Program Manager/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. 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.) and serve as liaison between internal team members, investigative sites, and CROs. Lead in the management of clinical study timelines and budget by utilizing appropriate project management tools, identifying and selecting vendors, managing vendor contracts, and ensuring 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. 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 the 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 to the 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. Hands‑on experience in running early‑stage and healthy volunteer clinical trials within an industry environment. Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP. Experience in the selection of CROs/vendors and the management of external resources. 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. 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 multitasking, 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
Has familiarity working with vendor systems/portals (eTMF, EDC, IRT, CTMS). Oncology and/or Healthy Volunteer studies experience strongly preferred. Desired Skills and Experience
Clinical Trial Management, Clinical Operations, GCP, ICH Guidelines, FDA Regulations, CRO Management, Vendor Management, Trial Master File (TMF), TMF Management, Clinical Study Documentation, Project Management, Budget Management, Cross‑functional Team Leadership, Clinical Data Science, Regulatory Affairs, Pharmacokinetics, Clinical Study Reports, IND, NDA, EDC, eTMF, IRT, CTMS, Interactive Response Technology, Central Lab Management, Imaging Vendor Management, Study Drug Accountability, Monitoring Oversight, Data Surveillance, Data Discrepancy Resolution, SOP Development, Clinical Research, Early‑stage Clinical Trials, Healthy Volunteer Studies, Oncology Clinical Trials, Microsoft Office Suite, MS Project, Smartsheet, Team Mentorship, Stakeholder Management, Timeline Management, Contract Management, Issue Resolution, Risk Management, Pharmaceutical Industry, Biotech Industry, Bachelor's degree in Biological Sciences, RN, 5‑7 years Clinical Trial Management Experience Additional Information
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.
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$80.00/hr - $90.00/hr Senior Clinical Trial Manager
W2 Contract-to-Hire Salary Range:
$166,400 - $187,200 per year Location:
Redwood City, CA - Hybrid Role Job Summary
This is a unique opportunity for a 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 into the Program Manager/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. 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.) and serve as liaison between internal team members, investigative sites, and CROs. Lead in the management of clinical study timelines and budget by utilizing appropriate project management tools, identifying and selecting vendors, managing vendor contracts, and ensuring 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. 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 the 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 to the 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. Hands‑on experience in running early‑stage and healthy volunteer clinical trials within an industry environment. Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP. Experience in the selection of CROs/vendors and the management of external resources. 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. 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 multitasking, 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
Has familiarity working with vendor systems/portals (eTMF, EDC, IRT, CTMS). Oncology and/or Healthy Volunteer studies experience strongly preferred. Desired Skills and Experience
Clinical Trial Management, Clinical Operations, GCP, ICH Guidelines, FDA Regulations, CRO Management, Vendor Management, Trial Master File (TMF), TMF Management, Clinical Study Documentation, Project Management, Budget Management, Cross‑functional Team Leadership, Clinical Data Science, Regulatory Affairs, Pharmacokinetics, Clinical Study Reports, IND, NDA, EDC, eTMF, IRT, CTMS, Interactive Response Technology, Central Lab Management, Imaging Vendor Management, Study Drug Accountability, Monitoring Oversight, Data Surveillance, Data Discrepancy Resolution, SOP Development, Clinical Research, Early‑stage Clinical Trials, Healthy Volunteer Studies, Oncology Clinical Trials, Microsoft Office Suite, MS Project, Smartsheet, Team Mentorship, Stakeholder Management, Timeline Management, Contract Management, Issue Resolution, Risk Management, Pharmaceutical Industry, Biotech Industry, Bachelor's degree in Biological Sciences, RN, 5‑7 years Clinical Trial Management Experience Additional Information
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.
#J-18808-Ljbffr