Local Study Associate Director

Work Schedule

Environmental Conditions

Job Description

Join Us as Local Associate Director CTM Make an Impact at the Forefront of Innovation

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs spanning 2700 clinical trials across 100 countries in the last 5 years.

As part of our expert team youll have the opportunity to ensure operational excellence that makes a real difference in organizational performance. As Associate Director CTM you will lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed

resources budget and timelines complying with client procedural documents international guidelines such as ICH-GCP as well as relevant local addition to leading LST(s) the Local Study Associate Director (LSAD) may perform site monitoring as needed to support the flexible capacity model. The LSAD is responsible to ensure that sites are identified site qualifications performed set up initiated monitored closed and documentation archived.

What Youll Do:

• Has the overall responsibility for the study commitments within the country and for timely delivery of data to required

  quality.

• Leads Local Study Team consisting of CRA(s) CSA(s) for assigned study/studies

• Leads and optimizes the performance of the Local Study Team(s) at country level ensuring compliance with client procedural

  documents ICH-GCP and local regulations.

• Ensures as required that clinical and operational feasibility assessment of potential studies is performed to the highest

  quality.

• Coordinates the site selection process by identifying potential sites/investigators performing initial Site Quality Risk

  Assessment and conducting Site Qualification Visits to evaluate suitability and quality risks.

• Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works

• together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory

  Authority for the duration of the study and in line with local regulations.

• Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study

  budget in client clinical studies financial system by regular checks of the system and financial reports (as agreed with Director

  SMM/ Director Country Head.

• Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.

• Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs as

  required including any relevant translations and in line with relevant client SOPs and local regulations.

  Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected

  and verified for correctness prior to setting sites ready to enroll and in line with client SOPs.

• Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction).

• Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and

  regulations.

• Oversees manages and coordinates monitoring activities from site activation through to study closure at country and site

  level in accordance with the Monitoring Plans.

• Reviews monitoring visit reports (as required and following client SOPs) and pro-actively advices the monitor(s) on study

  related matters.

• Performs any required co-monitoring Accompanied Site Visits/training visits with study CRAs.

• Proactively identifies risks and facilitates resolution of complex study problems and issues.

• Organises regular Local Study Team meetings on an agenda driven basis.

• Actively works towards achieving good personal relationships with all Local Study Team members sites staff and global

  stakeholders.

• Reports study progress/update to the Global Study Associate Director/ Global Study Team including SMM Lead.

• Contributes to patient recruitment strategy including regular communication with participating Investigators as

  necessary.

• Develops maintains and reviews risk management plan on country study level proactively manages sites stakeholders

  local and global vendors and customers to ensure risks are timely identified mitigated and managed.

• Communicates and co-ordinates regularly with National Co-ordinating Investigator / National Lead Investigator on

  recruitment and other study matters if applicable.

• Plans and leads National Investigator meetings in line with local codes as required.

• Assists in forecasting study timelines resources recruitment budget study materials and drug supplies.

• Ensures relevant systems required to facilitate business critical license to operate activities (for example Safety Reporting Regulatory submissions Clinical Trial Transparency) are set-up updated and access is organized at country level.

• Ensures accurate payments related to the study are performed according to local regulations and agreements.

• Participates in training and coaching new members of the Local Study Team ensuring compliance with ICH-GCP and client procedural documents.

• Ensures completeness of the eTMF and ensures essential documents are uploaded in a timeline manner to maintain the eTMF Inspection Ready.

• Ensures that all study documents are ready for final archiving and completion of local part of the eTMF.

• Plans and leads activities associated with audits and regulatory inspections in liaison with CQAD and QA.

• Provides input to process development and improvement.

• Provides regular information to Line Managers at country level on studies and planned study milestones/key issues.

• Updates Line Managers about the performance of the CRAs/CSAs.

• Ensures that study activities at country level comply with local policies and code of ethics.

• Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.

• Ensures compliance with clients Code of Ethics company policies and procedures relating to people finance technology security and SHE (Safety Health and Environment).

• Collaborates with local Medical Affairs team.

• Supports SMM in different initiatives (local regional or global) as agreed with the SMM Line Management.

Education and Experience Requirements:

• Bachelors degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 10 years).
• 5 years of management responsibility
• Proven leadership skills
• Significant experience in Study Management within a
• pharmaceutical or clinical background
• Thorough knowledge of Patient Safety processes and local regulations
• Clinical study delivery operational experience
• Project management experience

In some cases an equivalency consisting of a combination of appropriate education training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.

Knowledge Skills and Abilities:

• Excellent & effective mentoring/leadership/supervisory skills
• Effective organizational and negotiation skills; effective at multi-tasking
• Superior interpersonal skills and proven ability to be creative in problem solving and conflict resolution
• Capable of utilizing problem-solving techniques applicable to constantly changing environment
• Experienced in motivating integrating individuals/teams inducting coaching and teaching direct reports
• Capable of effectively and proactively managing and coaching employees with performance issues
• Proven record to proactively direct and promote teamwork in a multi-disciplinary and/or multi-cultural team setting
• Expert knowledge of clinical trials in releveance to regulations and guidelines e.g. ICH/GCP FDA guidelines etc
• Excellent ability to evaluate medical research data demonstrate proficient knowledge of medical terminology and therapeutic areas
• Proficient knowledge with company practice and processes to provide guidance and direction
• Proficient in using company tools to ensure oversight of financial management of projects for direct reports as well other tools needed to manage the timelines and quality of the data
• Strong attention to detail
• Competent use of computer and company systems to manage performance
• Strong attention to detail ability to synthesisze and communicate complex information
• Strong knowledge of English language & grammar with effective written and oral communication skills

Working Conditions and Environment:

• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations frequent travels both domestic and international.

Why Join Us

When you join Thermo Fisher Scientific you become part of a global team that values passion innovation and a commitment to scientific excellence. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.

Apply today to help us deliver tomorrows breakthroughs.