*Home-based position - To be eligible for this position, you must reside in the same country where the job is located.
Position SpecificsThis sponsor-dedicated role provides country-level oversight of clinical trials from study start-up through database lock and closeout. Operating in a fast-paced environment with evolving priorities, the role ensures high-quality data delivery and regulatory compliance across all phases of the trial.
Candidates who will thrive in this role have expertise in drafting and managing informed consent process, managing site selection, patient recruitment strategies, and monitoring visit reports, while driving risk-based mitigation plans to proactively address study challenges. The position collaborates closely with cross-functional teams to support trial execution, maintain inspection readiness, and uphold GCP, SOP, and local regulatory standards.
Two years of clinical trial management experience is required within a role that is accountable for driving and owning local trial activites at the regional level. Additional InformationAssociate Clinical Project Managers (aCPM)/Local Trial Managers are an integral part of clinical trial delivery, liaising with clinical teams to improve patients' lives by bringing new drugs to the market faster. The aCPM is a member of the core project team responsible for project delivery of clinical studies to meet contractual requirements in accordance with SOPs, policies and practices. Clinical Project Management is focused on project delivery, productivity and quality resulting in strong financial performance and customer satisfaction. The aCPM supports the efforts of CPM to drive operational excellence and strategic leadership with our customers.
Essential Functions- Provide input in to the development of integrated study management plans with the core project team and/or sub-team.
- Accountable for assigned portion of clinical studies as per the contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
- Set objectives of project sub-team(s), according to agreed upon contract, strategy and approach, effectively communicate and assess performance.
- Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
- Monitor progress against contract and prepare/present project and/or sub-team information proactively to internal stakeholders. Support the project leader to prepare/present project and/or sub-team information proactively to external stakeholders.
- Identify risk (positive and negative) and contingencies and partner with project leader in problem solving and resolution efforts.
- Achieve project quality by identifying quality risks and issues, responding to issues raised by project sub-team members and partner with project leader planning/implementing appropriate corrective and preventative action plans.
- May serve as primary (for small projects) or back-up project contact with customer.
- Lead the efforts of a project sub-team, responsible for managing cross-collaboration of the sub-team to support milestone achievement and to manage issues and obstacles.
- Support the project leader in ensuring the financial success of the project.
- Forecast and identify opportunities to accelerate activities to bring revenue forward in partnership with the senior project leader.
- Identify changes in scope and partner with project leader to manage change control process as necessary.
- Identify lessons learned and implement best practices.
- May be assigned as the primary contact for vendors leading project vendor management and vendor management related activities as per project requirements.
Qualifications- Bachelor's Degree In life sciences or related field required
- 2 years clinical trial management experience
- Requires intermediate level knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education combined with experience
- Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. Broad protocol knowledge, therapeutic knowledge desired.;
- Communication - Strong written and verbal communication skills including good command of English language. Strong presentation skills.
- Problem solving - Strong problem solving skills.
- Organization - Planning, time management and prioritization skills. Ability to organize resources needed to accomplish tasks, set objectives and provide clear direction to others, experience planning activities in advance and taking account of possible changing circumstances.
- Prioritization - Ability to handle conflicting priorities.
- Quality - Attention to detail and accuracy in work. Results-oriented approach to work towards delivery and output.
- IT Skills - Good software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel and PowerPoint.
- Collaboration - Ability to establish and maintain effective working relationships with coworkers, managers and clients. Strong customer service skills.
- Cross-collaboration - Ability to work across geographies displaying high awareness and understanding of cultural differences.
- Finances - Good understanding of project financials.
The potential base pay range for this role, when annualized, is $68,400.00 - $232,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
