POSITION DESCRIPTION
The Sr Clinical Trial Manager will function as the study team leader to plan, organize, and coordinate all operational aspects of a clinical study from protocol development through database lock. The position will also ensure timely conduct of clinical studies according to protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all applicable regulations governing the conduct of clinical trials.
NOTE: we are currently looking to fill two positions.
JOB RESPONSIBILITIES
- Develop timelines to optimize the achievement of study goals and milestones
- Select and manage vendors (including CROs, central lab, product distributors, )
- Develop and negotiate study site budgets
- Manage investigational product supply, including accountability
- Ensure quality and timely delivery of clinical study data
- Coordinate activities with other functional groups, such as Regulatory, Safety, Biostatistics,
Additional responsibilities may include coordination of activities of clinical trial sites including:
- Conduct Site Qualification Visits (SQVs) to assess investigator’s staff, capabilities, and facilities
- Work with Clinical Research Organizations (CROs) to ensure coordination of Sponsor and CRO responsibilities, obligations are being met
- Assist in preparation and ongoing review of study documents (protocol, informed consent (ICF), case report forms (CRF), diary cards, study manuals) in accordance with regulations
- Ensure all local regulatory approvals are in place for conduct of trial
- Conduct study initiation visits (SIVs), including training of on-site personnel in all aspects of study requirement
- Conduct study site interim monitoring visits (IMVs) at intervals specified in monitoring plan, including training of on-site personnel in all aspects of study requirements
- Track monitoring visits, visit report deadlines as per SOP and/or monitoring plan
- Assist in auditing of clinical trial data for accuracy and consistency and arrange correction of errors as appropriate
- Ensure all local regulatory approvals are in place for conduct of trial
- Identify, assess and implement appropriate corrective activities to ensure trial progress
- Manage central and/or local labs and supplies
- Coordinate supplies for specimen collection and track shipments of samples for assays
- Monitor supply of investigational supplies
- Assist with product accountability at site and take appropriate action to resolve discrepancies
- Report, confirm, audit adverse events per protocol and SOPs
- Conduct study close-out visits (COVs)
- Document all trial information with adherence to applicable guidelines and SOPs
- Remain current with study data, amendments
- Maintain high level of familiarity with clinical literature of study area
- Present at Investigator Meetings
- Maintain ClinicalTrials.gov website information per SOP
JOB QUALIFICATIONS
- Minimum 8 years clinical drug development experience
- Experience in personnel management
- Experience in CRO selection and management, including drafting request for proposals (RFPs), bidding process,
- Experience in managing clinical trials (international preferred) in various therapeutic areas (pediatric orphan indications, preferred)
- Knowledge of FDA regulatory requirements and medical practice/techniques and terminology
- 25% travel required
EDUCATION AND SKILLS
- BA/BS in related field
- Ability to work within a team, including leadership skills
- Ability to organize and prioritize multiple tasks
- Excellent communication and interpersonal skills
- Attention to detail, organization, and problem-solving skills
Source: Indeed.com
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