Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

Senior Manager/Associate Director, Clinical Trial Management

Company: Synteract
Location: United States Anywhere, US None
Reference: 27727
Closing Date: 18 Feb 19
Type: Full Time
Salary (£): On Application
Benefits: Excellent

Job Summary:

Senior Manager/Associate Director, Clinical Trial Management - Anywhere, US Office based or Remote based   Who We Are Synteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies. With our mission of ”Bringing Clinical Trials to Life,” we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas...

Requirements:

Senior Manager/Associate Director, Clinical Trial Management - Anywhere, US Office based or Remote based   Who We Are Synteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies. With our mission of ”Bringing Clinical Trials to Life,” we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in Oncology, Neuro Degenerative Diseases, and Rare and Orphan Diseases, and in pediatric populations. Our mission is to support the innovation and development of better therapies in healthcare.   Position Overview The Associate Director, Clinical Operations is responsible for the overall coordination of the clinical team and monitoring of daily activities to ensure the successful completion of clinical trials.  S/he participates in the planning, implementation, monitoring and management of clinical trials in compliance with applicable regulations, ICH –GCP Guidelines and SOPs.  Additionally, s/he supports overall management of the department in collaboration with Clinical Operations senior management.  This role is responsible for Line management and resourcing of Clinical Trial Managers.    Specific tasks would include:

  • Interacts with applicable pharmaceutical, biotechnology clients and vendors to ensure that contractual obligations related to clinical activities are met.
  • Acts in the role of, or provide support to, the primary clinical point of contact for Client representatives as well as SynteractHCR team members to ensure the timely initiation and completion of clinical trials.
  • Conducts daily, ongoing communication responding to inquiries from clinical sites and project team members; addresses client requests, as applicable.
  • Participates in initial client meeting identifying clinical study objectives.
  • Ensures clinical study team resources are continuously adequate; participates in the interview and selection of clinical personnel for studies.
  • Participates in the coordination and conduct of study specific training, as appropriate; ensures standards for monitoring and reporting are met.
  • Participates in the coordination and conduct clinical team meetings to monitor study progress and share best practice; includes the development of meeting agendas and minutes.
  • Ensures project-related Clinical data is tracked and maintained in an existing database, i.e. CTMS, EDMS, etc.; provides reports as applicable.
  • Ensures fully executed contracts are in place (client, sites, providers), as applicable.
  • Coordinates study specific payments, as applicable.
  • Contributes to the management of the clinical budget and out of scope documentation throughout the duration of the project.
  • Provides input to the Clinical Operations portion of proposals, budgets and contracts.
  • Supports Business Development in preparing and defending requests for proposals.
  • Contributes to the development of training programs to ensure opportunities for employee development and advancement.
  • Responsible for ensuring employee training plans are set up, followed and completed.
  • Mentors and trains CO personnel in clinical study monitoring and management and the relevant applicable regulations, ICH-GCP Guidelines; ensures standards for monitoring and reporting are met.
  • Performs co-monitoring visits as required and follows up on any identified training needs.
  • Responsible for completing employee appraisals, as required; communicates with superior and HR to review salary and recommend promotion (horizontal or vertical).
  • Assists in resolution of CO personnel performance issues; including termination as necessary.
  • Assesses employees and provides on-going feedback and recommendations for development.
  • Effectively manages workload of supervised staff, with continual assessment and adjustment as necessary.
  • Manages employee time off requests, timesheets and expense report approvals.
  • Contributes to the management and reporting of Key Performance Indicators (KPIs).
  • Coordinates the activities of team members with regard to the clinical operations tasks and responsibilities.
  • Contributes to the management of department utilization and evaluation and reporting of non-billable time.
  • Allocates resources with focus on efficiency, timelines and project deliverables.
  • Responsible for identifying the need for additional clinical employees in the department; participates in the interview process and works with HR in the final decision on candidates.
  • Assists in the development, modification and execution of company policies that affect immediate operations and may also have company-wide effect.
  • Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
  • Contributes to the development and revision of clinical SOPs and department guidelines to ensure adherence to applicable ethical, regulatory and clinical standards.
  • Develops, or supports the development of, clinical study documents, templates, plans, manuals and tracking tools.
  • Participates in the coordination and conduct of clinical department meetings; includes the development of meeting agendas.
  • Participates in the analysis and development of the Clinical Operations department budget.
  • Contributes to the planning and conduct of feasibility studies.
  • Provides oversight for regulatory submissions, as applicable.
  • Participates in audits as required; oversees follow-up activities and ensures timely implementation and completion of corrective action plans in close cooperation with QA, as appropriate.
Qualifications
  • Bachelor’s degree in a life science or related field of study or equivalent combination of studies, nursing qualifications, and/or work experience.
  • 10+ year’s relevant experience, including a minimum of 2 years directly managing others effectively.
  • Considerable depth of experience in clinical study management, monitoring, and in developing study-related documents.
  • In-depth knowledge of ICH-GCP guidelines and applicable regulations.
  • Intermediate proficiency in Microsoft Word, Excel, Outlook, Internet Explorer and the ability to learn Microsoft PowerPoint.
  • Effective verbal and writing skills; English + local language, if relevant.
  If you’re passionate about bringing clinical trials to life, we encourage you to apply today!    Synteract’s policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire. The Company will not sponsor applicants [to this position] for work visas.     

Apply for this job: Senior Manager/Associate Director, Clinical Trial Management

Contact Information:

Address:  SynteractHCR Deutschland GmbH
Albrechtstrabe 14
80636 Munich
Germany
Tel:  +49 89 12 66 80 0
Fax:  +49 89 12 66 80 2444
Website:  Visit Our Web Site

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.