Description : 

Support Clinical Operations activities for assigned clinical studies including study planning, study start-up activities, protocol execution and study close-out as directed by and in collaboration with the Sr./Director Clinical Projects. Ensure global clinical studies are managed according to Good Clinical Practice, local regulations, guidelines, and Standard Operating Procedures (SOP)

Location : Warren, New Jersey

Salary Range :  130-160K

Key Responsibilities : 

• Ensure effective oversight and management of Contract Research Organizations (CROs) and vendors by reviewing and approving key project documentation in alignment with study objectives, monitoring status reports and study metrics to support informed decision-making, participating in meetings and supporting the Director of Clinical Projects to proactively identify and resolve issues, ensuring consistent study monitoring through review of visit reports and co-monitoring activities, and overseeing country feasibility and site selection processes in collaboration with Medical Affairs to identify and approve high-quality investigators.

• Contribute to the writing/updating/ review of essential documents such as ICF, Protocols/Amendments, Clinical Study Reports.

• Support for Investigator Meetings, including slide creation and presentation(s)

• Participate in study system set-ups including EDC, eCOA; perform UATs as needed

• Responsible for the negotiation of Site Budget and CTAs in partnership with CRO and DBV Legal

• Oversight of overall study budget and invoice review to ensure study remains within budget and invoices are approved on a timely manner.

• Work cross-functionally, using clinical operations expertise to ensure effective contributions, execution, and delivery of study activities ensuring a common understanding of activities across all stakeholders/line functions

• Support DSMB charter creation, attend/ prepare for DSMB meetings

• Provide clinical support for Data Management including functional review of data.

• Actively contribute, as needed to the preparation of clinical parts of IND/NDA/BLA/AMM/IMPD/DSUR dossiers • Perform QC of TMF

• Mentor other members of Clinical Operations, including CTAs.
  

Qualifications : 

• +5 years experience in a Clinical Operations role working on international/global Clinical studies within the Pharmaceutical/Biotechnology Industries or with a CRO, particularly with trial management experience.

• Experience/track record of having worked effectively in a multi-cultural environment

• Experience working in a matrix/cross-functional corporate organization Technical & Functional Skills

• Good understanding of the drug development process and knowledge of Pharmaceutical Industry

• Knowledge and experience of GCP/ICH practice, and the regulatory and ethical environment of Clinical Studies

• Excellent organizational and management skills

• Scientific rigor, ability to analyze, interpret, write and report

• Good verbal and written communication skills

• Good computer literacy

Behavioral skills : 

• Curiosity: Keep on exploring uncharted territories. Always ask “why?” and more importantly “why not?”,

• Courage: Take smart risks, mentor each other to always do better & be accountable for our choices, our opinions, and our actions,

• Collaboration: Teamwork and spirit. Support each other and be equally involved in the achievement of our common goals,

• Credibility: Be transparent, follow through and build trust. Educate ourselves about our unique technology.