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Clinical Study Manager - FSS at Advanced Group

Posted in Management 30+ days ago.

Location: King of Prussia, Pennsylvania





Job Description:


OVERVIEW

We are currently searching for a skilled professional to join a well-known client's team as a Clinical Study Manager in King of Prussia, Pennsylvania. The Clinical Study Manager role will assist with clinical operational planning activities and support study execution. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.

RESPONSIBILITIES


  • Create and drive study level timeline

  • Assist with the collection of feasibility data and study budget issues

  • Ensure regulatory and GCP compliance

  • Oversee TMF with periodic audits

  • Contribute to vendor selection and management, including issue escalation

  • Support developing and managing study plans and all associated documents

  • Plan and coordinate IMP and non-IMP supplies

  • Participate in the development of proactive strategy and corrective action plan to address study issues

  • Consult with team for strategic selection of countries and sites

  • Help to ensure team and external partner(s) receive and document study specific training

  • Report key study performance information, including study start-up metrics, enrollment, data collection, timeliness, and quality

  • Facilitate study close-out activities through completion of Clinical Study Report

  • Co-monitor as needed

  • Maintain up to date knowledge of the therapeutic area/product candidate(s), clinical practice, competitors, and regulatory considerations

  • Use standard processes, tools, and procedures consistently for study execution

  • Serve as support for regulatory submissions, audits/inspections, and resolution of findings

  • Track contract execution and assist in resolution of site issues


EXPERIENCE

  • Minimum of 4 years of relevant clinical research (or related) experience within the pharmaceutical industry required

  • Detailed understanding of the drug development process and each step within the clinical trial process

  • Experience supporting the execution of global clinical trials (pharmaceutical or research institute)

  • Understanding of budget forecasting and management

  • Excellent knowledge of ICH guidelines/GCP and applicability to all stages of the clinical development process

  • Experience in scientific/medical research preferred

  • Specialist knowledge (e.g. immunology, coagulation disorders, pulmonology, virology, oncology, and cardiology) desired

  • Proficient in MS Project and computer literate in appropriate software

  • Excellent interpersonal and decision-making skills

  • Good ability to comprehend complex scientific concepts and data

  • Strong project management skills, including ability for simultaneous management of multiple projects

  • Excellent written and oral communication skills


EDUCATION

  • Minimum of Bachelor's Degree in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area required

  • Other degrees and certifications considered if combined with related clinical research experience

  • Master's Degree desired


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.


It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.