Contract Position

4 weeks ago

Ridgefield, United States InnoCom Full time
Job DescriptionJob DescriptionPosition: Clinical Trial ManagerLocation: Ridgefield, CTPay Rate: 12 monthsDuration: $2990/weekDuties:
  • As Clinical Trial Manager (CTM), accountable for the operational management of the local component of a clinical trial.
  • Level of oversight assures achievement of trial recruitment commitment, timelines, budget and internal/external quality standards.
  • Leads local trial team to ensure integrity of trial conduct, assurance of patient safety, and that local/regional component of trial is planned, conducted and reported in line with regulatory requirements.
  • Requires orchestration of local trial team, and integration with other functions as necessary throughout planning, conduct and closeout of trial.
  • Works within a complex GCP and regulatory environment and on global clinical trials with multidisciplinary, international teams and with various internal and external stakeholders including suppliers and investigational sites.
  • Represents the company for the function at internal and external meetings, e.g. with investigational sites or regulatory agencies/inspectors. Failure can have impact on project deliverables (e.g. timelines, costs, integrity of trial data), the reputation of BI with stakeholders and regulatory agencies.
  • More than one assignment in parallel requires balancing conflicting priorities. Is involved in design and implementation of new innovative method as working group member.
  • Leads the local trial team as the US Clinical Trial Manager (CTM) Trial Preparation, Conduct and Closeout: In collaboration with Site Monitoring Lead and CRAs, ensure Trial contact for CRAs, investigators and site staff.

Skills:
  • Strong communication skills in complex cross-functional matrix structures.
  • Articulates and aligns business strategy/plan on an ongoing basis, ensuring alignment between words and action.
  • Highly developed receptive communication skills and cultural sensitivity.
  • Solid project management, networking/stakeholder management and team leadership capability.
  • Understanding of the scientific and/or technical components of the clinical development process, and associated regulatory requirements.
  • Technical Expertise: Demonstrates knowledge across all aspects of clinical trial operations and execution. Knowledge in a relevant Therapeutic Area is an asset.
  • Dimensions of trial complexity for this project management role include protocol, trial subjects, sites, countries, suppliers.
  • Ability to work across several studies and in different Therapeutic Areas.
  • Leadership and Influence: Candidate's skills and capabilities in addressing complex situations, resolving conflicts, horizontal and vertical influencing.
  • Strategic Mindset: Embraces cross-functional initiatives, applying innovative learnings Identifies risks and plans mitigation.
  • Coordination and Oversight: Candidate's skills and capabilities in setting priorities, managing pace of activities, and efficient usage of resources. Ability and willingness to travel domestically (10-20% of time).
  • Assignment will be based remotely, but candiates should be willing to travel to Ridgefield CT, if onsite work is required.
Education:
  • Bachelor's degree plus a minimum of 6 years of experience in clinical research, preferably in the pharmaceutical industry; or Master's degree or PharmD plus a minimum of 4 years of experience in clinical research, preferably in the pharmaceutical industry; or PhD or MD plus a minimum of 2 years of experience in clinical research, preferably in the pharmaceutical industry.
Required Skills: CLINICAL TRIAL MONITORING,CLINICAL TRIAL,CLINICAL OPERATIONS,GCP,

Minimum Degree Required: Bachelor's DegreeNOTES: By responding to this job posting, you are consenting to be contacted via email, phone, or SMS. Message and data rates may apply. You can reply STOP to opt-out of further SMS messaging

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