Clinical Program Manager

Foster City, CA

Perm Salary

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OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as Clinical Program Manager. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity. 

RESPONSIBILITIES

  • Oversee successful implementation of Research program, expanded access programs, write study protocols, study reports, and regulatory documents with little supervision
  • Contribute to development of abstracts, presentations, and manuscripts 
  • Demonstrated ability to successfully develop, implement, manage and complete clinical trials 
  • Provides guidance and oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines?
  • Experience in managing staff as well as mentoring and developing junior staff is required 
  • Partner with cross functional teams to manage, adjust, and revise project timelines/budgets as necessary 
  • Communicate project status and issues and ensure project team goals are met
  • May represent the company at professional events
  • May represent the department at cross-departmental events 
  • Experience in developing RFPs and selection and management of CROs/vendors 
  • Functional expertise to initiate, author, or contribute to SOP development, implementation and training 
  • Recruit, hire, mentor and manage direct reports and support their professional development 
  • Anticipate moderately complex obstacles and client difficulties and implements solutions to achieve project goals 
  • Must be able to resolve problems using national and international regulations, guidelines and investigator interaction
  • Collaborate with local medical affairs colleagues on country specific studies and initiatives
  • Provide knowledge and expertise on country specific regulations, site experience, and suitability for development studies
  • Independently manages all components of complex studies, compassionate use programs and non-interventional studies

EXPERIENCE

  • Excellent interpersonal skills and demonstrated ability to lead is required 
  • May design and use all available vehicles for scientific communication within company. With limited supervision may participate in or lead departmental strategic initiatives 
  • Ability to participate in and/or lead departmental or interdepartmental strategic initiatives under limited supervision 
  • Ability to examine functional issues from a broader organizational perspective 
  • Strong communication and influence skills and ability to create a clear sense of direction is necessary
  • Thorough knowledge and understanding of FDA and EMA Regulations or relevant local regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials and non-interventional studies

EDUCATION

  • Minimum seven years of experience and a BS or BA in a relevant scientific discipline 
  • Minimum seven years of experience and an RN (2 or 3 year certificate)

To be a best-fit your strengths must include

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology 
  • Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines 
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure 
  • Problem-Solvers.  As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives   
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource  

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

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