Job Opening: Clinical Study Manager

“Bringing knowledge, experience and science together to discover, develop and deliver therapies for CNS disorders”

Are you a person who is collaborative, committed, and has a passion for contributing to the development of new molecules that target rare neurological disorders at their genetic source? If so, and you like multitasking in a mission-driven environment, then this might be the perfect job for you!

VICO Therapeutics B.V. is a Leiden-based biotech company with a focus on developing innovative antisense oligonucleotide therapies for rare neurological disorders (www.vicotx.com).

Clinical Study Manager

What will your job be:

The Clinical Study Manager (CSM) is responsible for executing aspects of clinical studies critical for VICO’s mission to develop new therapies against genetically defined rare neurological diseases with utmost attention paid to quality and safety aspects. Expected activities in a typical day include the planning, scheduling, and managing of clinical operations aspects of an ongoing study that it is in the latter phases of study initiation. This role provides a high touch service model to internal and external stakeholders (e.g. investigators and site staff in a clinical trial network and third-party vendors such as a CRO) as well as oversight of internal and external teams, including successful oversight and management of an existing highly motivated and friendly clinical operations staff. 

The ideal CSM takes a patient-centric approach to the clinical management portion of the trial by proactively identifying study execution risks and potential study participant concerns with utmost attention to participant safety and maintenance of study data integrity. Additionally, the CSM supports Clinical Operations staff with coaching and mentoring as well as involvement in department specific initiatives. Beyond these critical roles, there are future opportunities for career growth within this program and beyond in a robust and ethical biotech culture which is truth-seeking at its core and values individual characteristics such as competency, integrity, honesty, and respect for persons.  That said, VICO staff also know how to have fun and to enjoy the journey of clinical drug discovery and development that is core to our mission!

Your tasks include:

  • Creating and maintaining study specific plans. 
  • Driving the successful activation of trial sites according to time, quality/scope and budget parameters.
  • Planning and driving both patient recruitment and retention together with the VICO Clinical Operations team, inclusive of preparing and executing a site and patient recruitment and retention plan/strategy to motivate recruitment and study participation to meet milestones.
  • Ensuring the timely review of all visit reports, reviewing them for appropriate content to ensure quality GCP compliance.
  • May co-monitor or audit (CRO) CRAs according to project and business needs.
  • Monitoring of clinical operations metrics, activities and timelines.
  • Acting as a coach/mentor to staff within Clinical Operations Team. 
  • Ensuring timely data verification through review of data management reports and use of monitoring resources to optimize monitoring of clinical data.
  • Tracking and analysis of open actions, protocol deviations and assesses the financial health of the clinical aspects of the study.
  • Serving as a point of contact for VICO Leadership for all clinical management and monitoring concerns.
  • Assisting the project team in the creation and maintenance of the Trial Master File according to VICO and/or CRO SOPs.
  • Forward-facing role to investigators and site staff; internally leadership role to represent clinical operations along with colleagues to management team.

Preferred profile:

  • Minimum of a bachelor’s degree, or its equivalent from an accredited institution, in a clinical, biological, scientific, or health-related field; or equivalent work experience.
  • At least 5 years of clinical research experience as a CRA, Clinical Lead, Project Manager (or equivalent) of which at least 3 years of clinical monitoring experience is required.
  • At least 2 years previous Clinical Oversight experience or equivalent.
  • Effectively communicating expectations using proper oral and written language.
  • Strong knowledge of ICH / GCP regulations.
  • Advanced knowledge of FDA Guidance Documents, EU Directives, and other relevant regulatory guidelines.
  • Strong people management skills to motivate and lead.
  • Collaborative team player with demonstrated ability to drive and lead consensus.
  • Ability to multitask and work effectively in a fast-paced environment with changing priorities.
  • Strong negotiation skills.
  • Strong presentation skills.
  • Excellent organizational and time-management skills, able to prioritize work to meet deadlines.
  • Accountable, dependable, and demonstrated commitment.
  • Self-starter with ability to act on own initiative.
  • Maintains a positive, results oriented work environment.
  • Advanced communication skills.
  • Independency in CSM activities requiring a minimal supervision.

What do we offer?

  • Competitive salary, including holiday allowance 
  • Performance bonus
  • Possibility for hybrid working 
  • Good pension scheme
  • Travel allowance and work-from-home allowance
  • Laptop 
  • Several social activities

Our small team is dedicated to bringing new therapeutics to those patients who need it. The company atmosphere is pleasant and informal, contributing to a particularly friendly working environment.  If this description sounds appealing to you, then we look forward to receiving your application!

Interested?

If you are interested in joining our mission to continuously discover, develop and deliver therapies then please send your full resume and application to careers@vicotx.com or submit it via the contact form.

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