Manage all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP
In accordance to project specific requirements, may assume Lead CTM responsibilities on regional level, Clinical Study Manager (CSM) responsibilities or take on additional responsibilities, e.g. process improvements, manage complex programs, have wider management or project coordination responsibilities
Develop clinical tools (e.g. Monitoring Plan, 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)
May 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 as needed to meet deliverables of the project
Regularly communicate with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained
Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies
Responsible for the timely archiving of documents and study materials for the department
Ensure achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution
Continuously monitor clinical trials to assess performance and ensure contractual obligations are met
May routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials
Communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues
May coordinate all start-up activities and ensure that essential document quality meets the expectation of Regulatory Compliance Review
Ensure timely regulatory submissions (if appropriate) are addressed
Reviews and follows up on all questions raised by ethics committees
Provide input into preparation of forecast estimates for clinical activities
Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements

Requirements

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years)
CTM and/or GCTM experience will be needed
Preferred therapeutic experience: Dermatology, GI, (UC/CD), Cardiovascular, Liver, Nephrology, Immunology, Rare Disease, Diabetes, Obesity, Dyslipidemia, Women's Health, Rheumatology, (RA, SLE, Gout), Cell & Gene Therapy and CAR-T in Autoimmune
Strong leadership skills, effective at mentoring and training, and capable of motivating and integrating teams
Strong planning and organizational skills to enable effective prioritization of workload and workload of team members
Strong interpersonal and problem-solving skills to enable 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
Capable of evaluating 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 e.g. ICH/GCP, FDA guidelines, etc.
Strong computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.
Capable of independently managing clinical only studies.

Benefits

A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

clinical monitoringproject managementregulatory submissionsclinical resource managementbudgetingforecastingrisk managementchange managementCRF designdata quality plan

Soft skills

leadershipmentoringorganizational skillsinterpersonal skillsproblem-solvingcommunication skillsattention to detaildecision makingteam integrationworkload prioritization

Certifications

Bachelor's degreeCTM certificationGCTM certification