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Senior Study Associate

4 months ago

UK, UK, United Kingdom Eliassen Group Full time

Sr Clinical Study Associate, Clinical Operations


OBJECTIVES/PURPOSE:

The Senior Clinical Study Associate (CSA) will independently perform tasks related to planning, and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan.

  • Provide support for critical day-to-day clinical study activities, including regulatory inspection readiness, in accordance with established protocols under the general supervision of the FSP Manager.
  • Collaborate with Clinical Operations/Study Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model.
  • Perform departmental tasks as needed.


ACCOUNTABILITIES:

The Senior Clinical Study Associate (CSA) will independently perform tasks related to supporting planning, and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan. The Senior CSA will provide support for critical day-to-day clinical study activities, including regulatory inspection readiness, in accordance with established protocols under the general supervision of the FSP Manager. The Senior CSA will collaborate with Clinical Operations Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the operating model. The Senior CSA will also perform departmental tasks as needed.


For assigned business, non-critical studies or regional studies, provide support for study activities, including but not limited to:

  • Review and/or approval of study documentation, including essential document packets, study plans, informed consent forms, etc.
  • Supporting/oversight of risk-based monitoring.
  • Attendance of key team meetings as required; may make presentations (e.g. data, etc.).
  • Supporting regulatory inspection readiness (e.g. preparation of materials and/or participation during regulatory inspections.)
  • Support clinical trial systems (e.g. CTMS/TMF/COMPASS(?) associated activities for selected studies
  • Supporting vendor contract administration as required.
  • Support study close-out activities, e.g. financial reconciliation
  • Supporting additional ad-hoc activities as needed, as agreed with Manager(s). Provide support for departmental tasks, including but not limited to:
  • Maintaining knowledge of systems and processes.
  • Attending internal and external trainings as needed and maintaining up-to-date training record


EDUCATION/COMPENTENCIES/SKILLS:

Bachelor’s degree or equivalent international degree required.

Experience

  • 2-4 years’ experience in pharmaceutical industry, clinical research organization, or related role.
  • Experience in Phase 2 and 3 studies and global/international studies is advantageous.
  • Experience working across multiple therapeutic areas (including oncology) is advantageous.

Skills

  • Knowledge in global/regional regulatory and compliance requirements for clinical research.
  • Demonstrated excellence in task management and cross-functional collaboration.
  • Excellent communication skills.
  • Excellent teamwork, organizational, interpersonal, and problem-solving skills.
  • Fluent business English (oral and written).


EXPERIENCE:

Technical/Functional (Line) Expertise:

Understanding and application of GCP, Regional, ICH, and applicable regulatory standards governing clinical research.

Comfortable with technology and able to learn new systems quickly.

Strong knowledge of MS Word, Excel, PowerPoint, and Outlook.

Leadership:

Managing deliverables.

Decision-making and Autonomy:

Ability to work in a fast-paced environment with demonstrated ability to manage multiple competing tasks and demands.

Ability to work with timelines and complete tasks according to deadline.

Problem solving study-related issues; demonstrating resourcefulness and independence; escalation of issues as needed.

Interaction:

Must be able to professionally interact and communicate with internal departments (Legal, Insurance, R&D functions, etc.), CROs, and external vendors.

Ability to effectively collaborate with both internal and external study team.

Ability to work in a matrix environment.

Coordination with external vendors as needed.

Complexity:

Requires strong attention to detail in composing and/or proofreading and/or approving study materials, establishing priorities, scheduling, and meeting deadlines

Ability to take ownership and manage tasks, as well as communicate effectively.

Assigned clinical studies may be high complexity and/or high risk.

More than one study and/or more than one program may be assigned.

Interactions with study teams and other colleagues are both local and remote (in varying locations and timezones).

LOCATION & TRAVEL

Home Based, Up to 10% Travel including overnight and international locations

START & TERM

ASAP, Multi-Year Ongoing Role