Clinical Trial Manager

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Location
Bridgewater, NJ
Salary
$1 - $1
Hourly
$1.00 - $1.00
Job Type
Direct Hire
Date
Nov 15, 2018
Job ID
2624573
The CTM will work closely with the Director, Clinical Operations and Clinical Development team on the design, execution and oversight of clinical trials (all clinical phases) related to pharmaceutical product development and registration. 
The CTM is responsible for the overall operational planning and activities for the implementation and conduct of studies (clinical trials, IIT studies, compassionate use and registries) including data management activities, ensuring that clinical studies are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements and within established timelines and budgets.  The CTM is involved in the scientific conduct of the study and acts as the leader of operational disciplines to guarantee release of high quality data in close collaboration with other department representatives (e.g., Regulatory Affairs, Project Management) and external vendors (CRO, Data Management, Biostatistics, Medical Writing, etc.).
 
DUTIES AND RESPONSIBILITIES
  • Contribute to the development and review of clinical study protocol synopsis, protocol and amendments to ensure operational feasibility.
  • Contribute to development and review of the Case Report Form (CRF) content and testing of the final CRF. 
  • Actively participate in clinical contract research organization (CRO) and vendor identification, selection and oversight.
  • Oversee study start-up activities including; feasibility and site selection.
  • Develop study-specific procedures, study plans and documents including Clinical Monitoring Plan, Data Management Plan, Data Validation Plan, Case Report Forms (including testing) and completion guidelines, Data Review & Surveillance Plan and/or other operational and essential documents.
  • Review vendor-developed or co-developed documents (e.g., specifications, scope of work, operational manuals, communication plans, retention and recruitment plans, data transfer plans, etc.) as requested to provide operational input (including on-time and high quality). 
  • Ensure appropriate testing/UAT are performed as required (e.g., eCRF screens, database structure, data loading, etc.).
  • Ensure that clinical and data management standards are followed for the study data management
  • Ensure proper oversight and communicate to teams on monitoring activities, data flow, and data validation and when applicable, coordinate the centralized review of procedures.  Perform patient data validation. 
  • Ensure study documentation is properly maintained and archived in the Trial Master File (TMF) and relevant systems and databases as required.
  • Coordinate and support field-monitoring activities through regular meetings/teleconferences and/or visits to clinical study sites and training of monitoring teams.
  • Prepare and lead data review meeting; organize and contribute to medical review meetings.
  • Collect, synthesize and report study information.  Maintain and provide information for monthly study summary (including enrollment curves and timelines) in a timely manner.
  • Participate in the development/follow-up of the study budget and selection and management of vendors.  Define needs, tasks and responsibilities of external vendors, review contracts, estimate costs of logistical aspects of the study and ensure tracking of payments for operational aspects of the study in collaboration with the Finance department.
  • Develop and oversee Key Risk Indicators and Key Performance Indicators and address and escalate issues and trends, as needed.
  • Assist in preparation and oversight of study audits/inspections both internal and external.  Ensure preparation and proper responses to audit/inspection reports & consolidation of findings and communicate important observations to VP, Clinical Development. 
  • Perform periodic Trial Master File quality review.
  • Contribute to development and review of department processes and procedures.
  • The CTM is accountable for operational oversight of the clinical program conducted within Clinical Development. He/she coordinates with CRO personnel working on the designated program to ensure operational consistency, to identify possible synergies, and to ensure that the team works closely together to meet the program goals on time and with high quality. 
  • The CTM is the primary responsible person for escalation of program issues/information within Clinical Development and will ensure that the VP, Clinical Development and Project Team is being provided with regular reporting on the program progress.  The CTM provides input to help ensure alignment according to risk adjustment and study milestones.
  • The CTM will work with external vendors in the planning and execution of Investigator Meetings both domestic and international.
  • Travel is required up to 20%, both domestic and international.
 
EXPERIENCE AND QUALIFICATIONS
  • Requires 10+ years of professional experience within the pharmaceutical industry or clinical-related discipline including at least 8 years clinical research experience.
  • BS/BA degree or equivalent (background in life sciences preferred)
  • Capable of interacting effectively with scientists and managers; serve as internal consultant on assigned area and liaise with external organizations on projects.
  • Extensive working knowledge of international regulations, guidelines and good practices pertaining to clinical trials.
  • Strong leadership, project management and planning skills.
  • Proven ability to demonstrate strong decision-making and problem-solving skills.
  • Excellent verbal and written communication skills including ability to clearly articulate information and interact effectively with cross-functional team members.
  • Ability to prioritize and work within established timelines, in a fast-paced environment.
  • Ability to understand and convey scientific information to audiences of different backgrounds.
  • Ability to work both independently as well as in a team environment.
  • Good working knowledge of standard computer office software such as Word, Email system (Outlook), PowerPoint and Excel.
  • Strong analytical abilities and attention to detail.
  • Strong organizational and time management skills.
  • Flexibility to manage shifting demands and changing priorities, proactively looking for ways to contribute.
  • Ability to anticipate and timely escalate issues and to define appropriate action plans.
  • Experience in managing and leading international meetings (Clinical Trial Team, advisory board meeting, etc.).
  • Ability to work in an international environment with internal and/or external partners (CROs).
  • Knowledge of industry data management standards and practices.
  • Demonstrates critical thinking, sound judgement, and initiative to solve problems.
  • Ability to perform all essential functions of the position, with or without reasonable accommodation.