Sr. Clinical Scientist

Lexington, MA

Contract To Perm

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OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as Sr. Clinical Scientist in Lexington, Massachusetts.  This role will work with cross-functional and global collaborations to integrate broad medical and scientific input into client development programs and clinical development plans for assigned programs and molecules.  Depending on corporate/programmatic needs and individual aptitudes, the role may primarily focus on Safety, Clinical or Scientific Research aspects of assigned programs

RESPONSIBILITIES

  • Preparing and/or assisting with preparation of key documents e.g. Investigator Brochures, regulatory submission documents, internal and external presentations
  • Preparing synopses and protocols, including writing, reviewing, amending and cross-functional facilitation as appropriate
  • Participating in clinical development plans for assigned compounds; reviewing safety, primary efficacy variables, and laboratory data
  • Reviewing scientific literature and prepare presentations, regulatory submission documents, etc
  • Collaborating with and support interactions with clinical sites as needed
  • Reviewing clinical data including: safety, primary efficacy variables, and laboratory data

EXPERIENCE

  • Minimum of 2 years working in a data-driven environment
  • Oncology experience required
  • Working knowledge of clinical trial design and execution
  • Experience in protocol development and regulatory submissions
  • Adherence to the highest standards for trial conduct, patient safety and data integrity
  • Medical/technical writing and basis statistics expertise preferred
  • Working knowledge of GCP, ICH Guidelines and standard medical terminology
  • Facility with Microsoft Office applications (eg, Excel, Powerpoint)
  • Proficiency in literature searches and standard data mining, interpretation and presentation
  • Ability to assimilate technical and scientific information accurately and quickly
  • Ability to work with cross-functional teams and meet deadlines in a fast-paced work environment

EDUCATION

  • Minimum of RN, PharmD, DO, or MD in biotech, pharmaceutical industry, clinical setting or equivalent

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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