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Sr. Clinical Trial Manager
700 Saginaw Drive Redwood City, CA 94063 US
Job Description
Clinical Trial Manager - CTM
The Opportunity:
This is a unique opportunity for a Clinical Operations Professional. As a Clinical Trial Manager (CTM) / Sr. Clinical Trial Manager (Sr. CTM), you will be responsible for acting as a central contact for the clinical study team(s) and assist with the execution and clinical trial CTM Responsibilities (will also need to meet the General Responsibilities):
Sr. CTM Responsibilities (will need to meet all responsibilities [General and CPM]):
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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 liaison between internal team members, investigative sites, and CROs.
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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.
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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.
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Follow up and follow through on team action items and identification, escalation, and resolution of issues as needed.
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Assess adequacy/feasibility of potential clinical investigators and sites, including qualification of investigators, evaluation of facilities, personnel, patient referral base, and adherence to GCP.
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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.
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Provide support, mentorship, guidance, and direction to Clinical Trial Assistants (CTAs) and Clinical Trial Management Associates (CTMAs), as appropriate.
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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.
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Support other Clinical Operations activities as appropriates.
Required Skills, Experience and Education:
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RN or Bachelor’s degree in biological sciences or health-related field required.
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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.
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Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP.
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Experience in selection of CROs/vendors and management of external resources.
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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.
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Excellent written/verbal communication and interpersonal skills.
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High sense of priority and commitment to excellence in the successful execution of deliverables.
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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.
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Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.
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Travel may be required (~15%).
Preferred Skills:
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Decision-making skills
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Has familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).
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Oncology experience, early and/or late stage, strongly preferred.
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Knowledge and/or familiarity with EMEA/APAC region(s) clinical trial operations.
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Attention to detail.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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