Company:  Confidential

Job Title: Senior Clinical Trial Manager/Associate Director Clinical Operations

Job Number: 25031

Location: Waltham, MA

Job Description

As a major contributor to the successful execution of clinical trials, perform a key role in building and maintaining relationships with Investigators and other study site personnel, CRAs and CRO team members. Based on a thorough understanding of the mechanics of conducting clinical trials, closely supervise all aspects of Clinical Trial Operations, including clinical project management, oversight of study center activities, CRA monitoring activities and vendor management.

Responsibilities

  1. Directly oversee contract CRAs, CRO study team(s), clinical sites and vendor(s) on assigned studies to ensure consistency of methods, interpretation and approach with other Syndax sponsored studies;
  2. Develop information/consent forms, study training materials, case report forms and study tools for assigned study;
  3. Conduct training for logistics of the clinical trial including protocol contents and coordinating trial materials;
  4. Oversee monitoring activities and conduct clinical site initiation visits, co-monitoring and close-out visits, as needed;
  5. Manage study timeline and provide study progress reports to management;
  6. Plan ahead and provide solution options for handling problems that develop;
  7. Oversee to ensure that paper and electronic filing systems are maintained appropriately and in a timely manner;
  8. Maintain tracking for study metrics essential to managing the study closely (patient visit information, data entry, monitoring and data cleaning information, etc.);
  9. Ensure that all tasks that contribute to the conduct of a clinical study are completed according to GCPc and SOPs, as well as on time and within budget;
  10. Assist in the development and review of protocols, investigator brochures, clinical study reports and other clinical documents and regulatory filings as needed.

Required Skills

Minimum Requirements:

  1. Bachelors’ Degree in life sciences or healthcare discipline; Master’s Degree preferred
  2. At least 5 years of clinical trial management experience and at least 2 year of clinical monitoring experience, in the biotech/pharmaceutical industry
  3. Oncology trials experience is required; hematology experience is preferred
  4. Working knowledge of GCPc and FDA and ICH regulations and guidelines
  5. Experience with international clinical trials and managing external service providers, CROs and contract CRAs
  6. Good understanding of cross functional areas including data management / biostatistics, regulatory affairs and pharmacovigilance
  7. Proven verbal and written communication skills; enjoys interacting with others regularly
  8. Able to prioritize tasks and work independently

Able to travel an average of 20%, both domestically/globally

 

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