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Global Clinical Trial Project Manager - Cambridge, MA or East Hanover, NJ
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Do you want to watch clinical development change, or do you want to be the one to shape it?


Because we’re hoping you’re here for the latter.


Who are we?

We Are PRA.


We are 15,000+ employees strong, operating in more than 85 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting live saving drugs into the hands those who need them most.


Who are you?

You are a forward thinker. You are an innovator that refuses to settle. You want to push the boundaries and change not just what it means to be a Global Clinical Trial Project Manager you want to change the future.  You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.


Still here? Good. Because if this is you, we’d really like to meet you.


  • What will you be doing?


    As a Global Clinical Trial Project Manager, you will be accountable for all aspects of the management and clinical execution of early phase clinical trials across multiple therapeutic areas within Translational Medicine (TM). You lead the planning and implementation of all operational aspects of clinical trials from study concept to reporting according to timelines, budget, operational and quality standards. You are responsible for program level activities and may have project lead roles that include strategic partnering and within Clinical Sciences & Innovation (CS&I) as well as Global Pharma throughout the development of a compound or complex patient populations, oversight and understanding of all CS&I trials within that project, oversee junior team members and lead a global study team, participate on project level decision making, manage scientifically and operationally complex studies.


    CS&I is part of Translational Medicine, a single global team of Physicians and Scientists that bridge drug discovery and clinical application. The CS&I group is a global team of Clinical Scientists and support functions that plan and manage Novartis Institutes for BioMedical Research Phase I and Phase IIa clinical trials worldwide. Our trials profile safety, tolerability, pharmacokinetics, pharmacodynamics, and early proof of efficacy of novel compounds in healthy volunteers and patients: key tasks include leading authorship of study protocols and input to study designs, identifying study sites and investigators, negotiating external study contracts, co-ordinating study execution and monitoring enrolment and data flow/scientific review.


    • Clinical Scientist for Phase I/II including multi-country / multi-center trials: The main focus will be on high complexity studies leading to clinical Proof-of-Concept or NDA registration
    • Responsible for leading and matrix managing the multidisciplinary Clinical Trial Team (CTT) and support functions to ensure that all trial deliverables are met. Chair CTT meetings, manage team actions, and actively track study progress to ensure completion according to specified timelines, budget and quality standards. Communicate study progress to CTT, CS&I Management, TA Heads and Project team members
    • Lead all aspects of study planning and collaborate with outsourcing/feasibility personnel, CTT members, local country office representatives and CRAs. Identify sites and manage study set-up, including responsibility for organizing and chairing investigator meetings, or site initiation meetings
    • Interact with investigator sites and CRAs/CROs/vendors to ensure a smooth study set up and a smooth study conduct, reviewing site performance, protocol deviations, and maintaining awareness of issues raised
    • Author of the Clinical Study Protocol, amendments and related documents, Informed Consent Form, Study Operations Manual, monitoring plan, and other study essential documents. Train and support CRAs/CROs on study protocol and related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects’ eligibility
    • You may support the Medical Expert on project documentation e.g. briefing books, IBs, Annual Safety Reports, responses to Health Authority questions, etc.
    • Lead the ongoing medical /scientific review of the clinical trial data (in collaboration with the Medical Expert and CTT), coordinate the data analysis and interpretation of first interpretable results, publications and internal/external presentations. Direct the data review and interactions with the Data Manager, Statistician, and third parties to ensure that high quality data are transferred/available in a timely manner
    • Accountable for Clinical Study Report writing and publication of studies, either directly contributing to and managing the report writing, or by liaising with the medical writing/narrative group to ensure that reports are completed according to current requirements



  • What do you need to have?


    Education:  PhD level scientist with life sciences background; PharmD; BSc or MSc in life sciences


    • At least 6+ years experience in international Pharma / Sponsor clinical trial management and execution, plus broad knowledge of drug development
    • Extensive knowledge of Good Clinical Practice
      Track record of successfully managing multiple concurrent complex global phase I and IIa, multi-country, multi-site clinical trials
    • Ideal therapeutic area experience: Autoimmunity, Dermatology, Musculoskeletal, Respiratory
      Office and clinical trial software IT computer literacy
    • Demonstrated leadership and problem-solving skills
    • Strong operational project management experience including excellent planning, prioritization, problem solving and organizational skills.
    • Used to managing multiple priorities
    • Clear written and verbal expression of ideas, a proactive communicator
    • Well-developed interpersonal skills with a proven track record of successfully interacting with and influencing a wide range of people, building strong positive relationships
    • High level of customer orientation awareness and focus
    • Used to working independently and in a team environment, being flexible and adapting to change
  • Minimum 5 years experience in clinical research, including a minimum 2 years full service project management experience or an equivalent combination of education and experience sufficient to successfully perform the key responsibilities of the job.
  • Reads, writes and speaks fluent English; fluent in language of host country.
  • A graduate degree or  undergraduate degree.
  • An undergraduate degree with 7 years of experience in clinical research and at least 3 years as a full service project manager. 
  • Or a Graduate degree with 5 years of experience in clinical research and at least 2 year as a functional team lead role or single service project management.



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