Senior Clinical Project Manager Job at Planet Pharma, Boston, MA

WkZ0cHdQd0UrRURYMEI5MGdkYy9hRFVHVHc9PQ==
  • Planet Pharma
  • Boston, MA

Job Description

Immediate Need for Senior Clinical Project Manager with a biotech company in Boston, MA. This is a full time permanent position. Remote 3 days, office based 2 days a week.

Must have small biotech experience, Phase I-III management experience, CRO oversight and international experience.

Rare disease is preferred but not required.

Sr. Clinical Project Manager (CPM) provides operational leadership of one or more clinical trials from protocol development through clinical study report, and ensure activities are executed in accordance with the protocol, ICH/GCP guidelines, applicable regulations, and company's policies and procedures and corporate goals. Responsibilities may include leading cross-functional study team(s) and/or the oversight of Contract Research Organizations (CRO) and vendors. The CPM will have a command of assigned studies, the ability to flex and adapt to dynamic situations, and will utilize critical thinking skills to facilitate risk mitigation analyses and problem solving.

Reporting Relationship

The Clinical Project Manager or Sr. Clinical Project Manager will report to the Vice President of Clinical Operations or designee

Duties and Responsibilities

  • Lead cross-functional teams to ensure studies are conducted one time, with quality and within budget
  • Develop and maintain study timelines through collaboration with internal and external stakeholders; ensure timelines remain on track through ongoing communication, collaboration and risk-mitigation strategies
  • Drive study start-up activities, including site and vendor identification, feasibility and selection
  • Effectively model and manage patient enrollment forecasts; implement risk mitigation strategies to ensure enrollment remains on track
  • Develop oversight plans for outsourced services; oversee vendors, including CROs, third-party vendors and consultants to ensure the timeliness and quality of services performed
  • Partner with CMC/clinical supplies to calculate drug projections and contribute to design and packaging of study supplies
  • Oversees monitoring and monitor performance, including adherence to the monitoring plan and applicable SOPs
  • Conduct monitoring oversight visits and site engagement visits to ensure the quality of vendor and site performance
  • Ensure effective and timely contract and budget negotiations with clinical sites and vendors
  • Lead and/or contribute to study risk assessment and risk mitigation. Proactively communicate risks to study members and senior staff.
  • Oversee the management of the electronic Trial Master File (TMF); ensure the TMF is created, maintained, monitored and closed out in accordance with the TMF plan and study timelines
  • Facilitate and manage cross-functional interactions with internal and external stakeholders to ensure relevant and timely communication of information and materials for decision making purposes as well as ensure adherence to study timeline.
  • Collaborate with medical research, data management, biostatistics, pharmacovigilance, and other functions to ensure data is processed in a timely manner for ongoing data review, interim analyses and final database lock.
  • Contribute to the writing and review of clinical documents such as protocols, informed consents, investigator brochures, DSURs, monitoring plans and reports.
  • Review and approve corrective action plans, participate in study-related audits.
  • Actively contribute to and implement best practices and standards for study management; participate in the development of initiatives and process improvement within Clinical Operations
  • Approach problem solving with a strategic, action oriented and positive attitude.
  • Manage/mento/train junior staff by actively participating in documentation, sharing industry standards, implementation of trial conduct best practices, and lessons learned
  • Assist with the development of policies, procedures and best practices in support of operational excellence
  • Other duties as assigned.

Educational Qualifications

A Bachelor's degree or higher degree (scientific discipline preferred)

Additional Qualifications

  • 4-7 years in trial management with a sponsor company managing various phases of clinical trials.
  • Experience overseeing vendors, including identification and mitigation of risks.
  • Experience leading cross-functional teams and meetings.
  • In-depth understanding of ICH/GCP guidelines and FDA regulations.
  • Understanding/working knowledge of Microsoft Word and Excel and Microsoft Project.
  • Critical thinking skills for problem solving and have the lateral and strategic thinking capacity to drive study(ies) and understand implications of decisions that affect study outcomes and timelines.
  • Strong interpersonal and negotiation skills.

Job Tags

Permanent employment, Full time, Contract work, Interim role, Immediate start, Flexible hours, 2 days per week,

Similar Jobs

The People Co.

Quality Assurance Manager Job at The People Co.

Our client, a leading North American manufacturer is seeking a QA Manager to be responsible for leading the QA team members with various inspections and activities in relation to the quality of product processed throughout the facility. This talented QA Manager with have...

Diamond Peak Recruiting

Construction Estimator Job at Diamond Peak Recruiting

 ...This position requires a thorough understanding of mechanical construction bidding processes and the ability to prepare large and complex...  ...prepare proposals using estimating software. Collaboration : Work on-site and/or in the main office, collaborating with various professionals... 

Eisenhower Foundation

IKEducation Operations Assistant Job at Eisenhower Foundation

 ...sometime in August and ending sometime in May. All employees are required to have a background check completed by the National Archives and Records Administration. This has no cost to it, but does require the applicant to provide identification materials and... 

Charter Schools USA

Principal Job at Charter Schools USA

 ...Who We Are Charter Schools USA (CSUSA) is one of the largest and highest performing education management companies in the United States, proudly serving over 82,000 students in over 150 schools in four states. Founded by Jonathan Hage in 1997, CSUSA's mission is a Relentless... 

Legacy Health

Hospitalist - SC Job at Legacy Health

 ...Legacy Health is currently seeking experienced clinician educators to join our dynamic and well established yet expanding Academic Hospitalist Program at our Salmon Creek Medical Center. Legacy Academic Medical Group offers: Attending physician supervising...