Job Title: Sr. Clinical Trial Manager Job Description The Clinical Project Manager is responsible for achieving the final clinical deliverable, typically clean data from evaluable patients as specified in the study protocol, within the time period specified in the customer contract. This role involves interpreting data on complex issues, making business decisions with line management support, and ensuring that all clinical deliverables meet the customer's time, quality, and cost expectations. The Clinical Project Manager maintains profitability by ensuring that clinical activities are conducted within the contract scope through efficient management of the clinical team. This position typically works independently on projects of moderate to high complexity and may assume regional lead or Clinical Study Manager responsibilities. Responsibilities + Manage all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP. + Develop clinical tools such as Monitoring Plan and Monitoring Guidelines in conjunction with the Data Quality Plan. + Contribute to the development of the Master Action Plan (MAP) for providing clinical related documents. + Ensure timely set up, organization, content, and quality of the relevant sections of the Trial Master File (local and central). + Participate in the design and development of CRFs, CRF guidelines, patient informed consent templates, and other protocol-specific documents as required. + Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings. + Collaborate with the clinical team and other departments to meet project deliverables. + Regularly communicate with the team and lead team meetings to ensure timelines, resources, interactions, and quality are maintained. + Implement and train standardized clinical monitoring processes within the study according to corporate standard policies. + Ensure timely archiving of documents and study materials for the department. + Prepare and monitor clinical activity timelines and metrics, providing status updates to the project manager. + Review monitoring visit reports and manage CRF collection and query resolution. + Continuously monitor clinical trials to assess performance and ensure contractual obligations are met. + Conduct Accompanied Field Visits (AFVs) and be accountable for project financials. + Communicate with study sites regarding protocol, patient participation, case report form completion, and other study-related issues. + Coordinate all start-up activities and ensure essential document quality meets the expectation of Regulatory Compliance Review. + Ensure timely regulatory submissions and follow up on questions raised by ethics committees. + Provide input into the preparation of forecast estimates for clinical activities. + Manage clinical resources, assign and delegate clinical responsibilities, and identify additional resource requirements. + In North America, where assigned to GPHS projects, may have limited line management responsibilities. Essential Skills + Bachelor's degree or equivalent and relevant formal academic/vocational qualification. + Previous experience comparable to 8+ years that provides the knowledge, skills, and abilities to perform the job. + Strong leadership skills, effective at mentoring and training, and capable of motivating and integrating teams. + Strong planning and organizational skills for effective prioritization of workload and workload of team members. + Strong interpersonal and problem-solving skills for working in a multicultural matrix organization. + Solid understanding of change management principles. + Comprehensive understanding of the practices, processes, and requirements of clinical monitoring. + Strong judgment, decision-making, escalation, and risk management skills. + Effective oral and written communication skills, including English language proficiency. + Capability to evaluate own and team members' workload against project budget and adjust resources accordingly. + Strong financial acumen and knowledge of budgeting, forecasting, and fiscal management. + Strong attention to detail. + In-depth understanding of relevant regulations such as ICH/GCP, FDA guidelines, etc. + Strong computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc. + Capability to independently manage clinical-only studies. Additional Skills & Qualifications + In some cases, an equivalency consisting of a combination of appropriate education, training, and/or directly related experience will be considered sufficient to meet the requirements of the role. Work Environment This position is 100% office home-based. Pay and Benefits The pay range for this position is $67.66 - $75.18 Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully remote position. Application Deadline This position will be accepting applications until Dec 20, 2024. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.