Project Manager V

NOTE: Remote option can be considered up to 2 days per week once up and running

Job Description

looking for someone with excellent study management skillsets they must have experience managing clinical trials.

The Process Project Manager (PPM) leads/ participates in transversal projects within the Clinical Sciences & Operations Scientific Core Platform (CSO SCP) for which changes/improvements to business processes are expected. The PPM will lead/participate in broad transversal projects with significant process improvement to business processes.

Skills:

An extensive knowledge of R&D, with past experience in clinical operations. In-depth knowledge of ICH/GCPs.

Quality focused with a high degree of personal accountability and commitment.

Strong knowledge of international good clinical practices (ICH) and thorough understanding of current regulatory requirements (FDA, EMEA) related/ applicable to the conduct of clinical trials, understanding of FDA Compliance Manual & EMA Compliance Manual

Knowledge about requirements of New Drug Application (NDA)/ Market Authorization Application (MAA) submissions and e-submissions

Excellent skills to communicate and collaborate with project teams, departmental associates, internal and external partners.

Demonstrated ability to anticipate problems/ changes impacts, consequences, and delays; work proactively and take the initiative for corrective measures.

Excellent team leadership skills

Strong facilitation skills: ability to lead effective cross-location and cross-functional meetings, through discussions on complex and potentially controversial topics.

Demonstrated ability to bring consensus among diverse cross functional teams and to drive results within established timelines

Results driven with attention to detail and quality while overseeing and connecting with contributing departments

Ability to recognize issues that may require escalation to management level.

Ability to multi-task, handling a wide range of small, medium and long-term assignments in parallel and dealing with urgent issues as they arise.

Ability to prioritize assignments in accordance with assigned project deadlines.

Excellent written and verbal skills.

Excellent presentation, interpersonal and communication skills (written and verbal)

Self-motivated, detail-oriented, with strong organizational/prioritization skills for the management of concurrent project

Bachelor degree or higher in a relevant scientific/health-related field.

12+ years’ experience in the pharmaceutical industry, with a minimum of 10+ years’ experience in clinical and/or quality operations-related roles (e.g., direct study management, monitoring, auditing)

For more information, Please contact

Akriti Gupta

(973) 967-3409

Morristown, NJ 07960